Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic neurosurgery is initiating a recall of all affected model numbers and lot numbers of the clip gun scalp clip system.Testing performed by medtronic showed that the outer sterile pouch of the product did not meet standards for package integrity. specifically, the testing demonstrated that the outer pouch could be compromised and possibly go undetected by the user which could potentially lead to patient infections.
Acción
Medtronic are advising hospitals to cease use of affected product. Medtronic will arrange for retrieval of affected items.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Brainlab has determined that due to a human error at a brainlab supplier, an unknown number of items within one specific production lot of brainlab drapelink adapters (left/right) were not manufactured according to defined specifications.Due to this manufacturing error the required reproducible rigid fixation between drapelink c-arm array and adapter cannot be ensured in all cases.
Acción
Brainlab is advising users to isolate units with the specified serial numbers from use. A Brainlab Customer Support Representative will contact customers to arrange a service visit to collect and replace the potentially affected item.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer pro med instruments (pmi) has been made aware of two breakages of the doro sterile disposable skull pins at the tip, which occurred during two surgical procedures. the breakages occurred at the very distal end of the conical part of the skull pin tip. these breakages did not cause any injury to the patient and pmi have not, to date, been made aware of any further adverse events.In a worst case scenario, this issue could lead to slippage which may require remedial action, loosening of the positioning and a delay in surgical procedure or the tip remaining in the skull, which could lead to subsequent complications such as wound healing.
Acción
Life Healthcare is requesting customers:
1. Review the Sponsor supplied Customer letter and ensure all users of the device are informed of this recall. If you have transferred the affected items to third parties, forward a copy of the Customer Letter to them;
2. Check your stock for affected Doro Pins Ref: PMI-3006-00 Lot 1704;
3. If you have affected items quarantine them immediately and complete the relevant section in the supplied form;
4. Check any records where the affected lot numbers have been used prior to this notice for discrepancies in the skull pins. If the tips have been noted as not being intact ensure that any remaining pieces are removed from the patient; and
5. Please complete the supplied reply form and return by email to regulatory@lifehealthcare.com.au
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer, cosman medical, has received complaints regarding nitinol rf (model tcn) reusable electrodes. after multiple reprocessing cycles, the epoxy resin which holds the tcn electrode in the hub can exhibit signs of damage. this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilising the device. the failure to completely remove any blood and/or tissue from the tcn electrodes prior to re-sterilisation creates a potential risk of infection and spread of blood borne pathogens to patients.Cosman medical is implementing an action for nitinol rf (tcn) reusable electrodes to convert them to single patient use electrodes (re-usable for one patient only). after single patient use, the used tcn electrode should be disposed of in accordance with the individual institution’s infectious material/biohazard waste control procedures. to date, cosman have not received any reports of patient injury related to this issue.
Acción
Action to be taken by users:
Cosman Medical is implementing an action for Nitinol RF (TCN) reusable electrodes to convert them to single patient use electrodes. After single patient use, the used TCN Electrode should be disposed of in accordance with the individual institution’s infectious material/biohazard waste control procedures. Unopened TCN Electrodes need to be identified as single patient use only (re-usable for one patient only). These devices are supplied non-sterile which require cleaning and sterilisation prior to use. These TCN electrodes may be used once the cleaning and sterilisation steps are completed.
Isolate any used affected items. A LifeHealthcare Representative will arrange collection and replacement.
Return the Reply Form provided by LifeHealthcare so they can validate that all customers have been advised of this action.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic have received three complaints from physicians regarding the dbs depth stop not being adequately secured to the lead. in two of the three complaints received, this resulted in initial dbs lead placement beyond the intended target, which was identified via intraoperative imaging and corrected with no report of patient harm. in the third instance, the issue was identified prior to lead insertion. analysis of these returned products indicate the threaded area of the depth stop screw did not extend far enough to allow it to fully secure the lead in the depth stop causing the slippage of the lead through the depth stop.
Acción
Medtronic is requesting surgeons who suspect that the depth stop is not tightening adequately onto the lead to discontinue use the affected device but instead, to complete the procedure using a depth stop from another Medtronic DBS lead kit. Surgeons are further requested to check the stimulation effect during the implant procedure and use imaging techniques to confirm lead placement, as stated in the DBS lead implant manual. For devices already implanted, surgeons are advised that no action is needed (since lead placement at the intended target location is expected to have been confirmed through intraoperative test stimulation, imaging, and/or therapy effectiveness).
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Specific stratamr adjustable valves & shunts may experience a condition which may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (csf). the condition can occur when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance. this higher than intended flow resistance is a result of the mri resistance key on the bottom of the valve’s rotor mechanism being placed on top of one of the mri resistance walls, instead of in one of the pressure setting wells. the incorrect valve rotor orientation can be caused by misalignment and/or off-center positioning of the stratamr locator tool, relative to the valve mechanism during the valve adjustment process. this condition may result in headaches, nausea, vomiting and lethargy. if left untreated underdrainage has the potential to lead to coma and death. to date, there have been no reports of death.
Acción
Customers are advised to discard and return any unused units to Medtronic. For products that have been implanted in patients, clinicians are reminded that for continued patient care that it is critical to properly align and center the Locator Tool over the valve mechanism to ensure that the valve is set at the desired pressure. Instructions that will aid in proper technique are included in the Instructions for Use and reiterated in the customer letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic has identified an increase in customer complaints about rechargers in an unresponsive error state, where the recharger is non-functional with a blank screen & beeping every 5 seconds. rechargers manufactured since november 2014 (serial # starting “nka4” or “nku4”) are more susceptible, with reports for 2% of these rechargers & 0.2% for those manufactured before november 2014. when the error occurs, the recharger is unable to recharge the neurostimulator until the recharger is reset. if the neurostimulator battery is allowed to become fully depleted, this can lead to loss of therapy and return of baseline pain levels and associated disease-specific symptoms. if the battery is allowed to remain fully depleted, it may over-discharge, affecting the battery capacity and the recharge frequency. for a subset of patients receiving dbs therapy, in rare instances, a loss of dbs therapy may result in a life threatening injury or death however no reports of this kind have been received.
Acción
Medtronic is working on a permanent solution and in the interim is providing the following workarounds:
1. To prevent the unresponsive error state, the Recharger should be plugged into the AC power supply (by aligning white triangles) prior to starting a recharging session of the neurostimulator and remain connected to the AC power supply until the recharging session has finished. Note: The AC power supply does not need to be plugged into a power outlet if the Recharger is charged.
2. To restore Recharger functionality if the unresponsive error state occurs, patients can contact Medtronic Neuromodulation Patient Services at 1800 652 972, or Customer Service on 1800 668 670, where they will receive instructions to reset their unresponsive Recharger. Treating physicians will also be provided with illustrated reset instructions with the customer letter. Patients should contact their physician immediately if they experience a return of symptoms. Note: This issue can recur after reset if the recharging instructions in point 1 are not completely followed.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
It has been identified that 16 medtronic neuromodulation dbs system pocket adaptors (0.08% reported rate of occurrence) have been identified with high impedance, resulting in decreased current being conducted through the device. some of the reported cases involved loss of therapy, return of symptoms, rebound effects and potential revision surgery to replace the device. there have been no incidents reported in australia. analysis of the returned devices found the cause of the high impedance to be conductor wire fractures near where the wire exits the neurostimulator connector block. in two cases, the issue was identified during implantation surgery, while the other 14 were identified after implantation and resulted in revision surgery.
Acción
Medtronic is reminding users of the device labelling specific to the handling of pocket adaptors and system integrity checking during implant procedures. This action has been closed-out on 03/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker neurovascular has become aware that some units of the target nano detachable coils do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.The most likely adverse health consequence from coil stretching is prolongation of the procedure, as the stretched coil needs to be removed from the patient and replaced. there is a potential of thrombus formation when the stretched coil is left exposed in the blood flow. additional intervention may be required to snare the stretched coil or pin it to the vessel wall with a stent if safe removal is not possible. this may result in thrombus or thromboembolism which can lead to stroke. there will be no long term adverse health consequence after a stretched coil is removed from the body.
Acción
Stryker is advising users to inspect stock and quarantine any remaining affected units for return. This action has been closed-out on 03/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Brainlab has detected that, when using the brainlab cranial navigation system, the following may have a significant effect on the overall navigation accuracy: • large distance between reference array and region of interest • major changes of the camera position relative to the reference array during the procedure those instances could potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure. in the worst case scenario, these inaccuracies may cause an inaccurate display of instruments by the navigation system, compared to the actual patient anatomy. if these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could ultimately lead to ineffective treatment, serious injury or even death of the patient.
Acción
Brainlab has developed a software update to improve navigation accuracy. Brainlab will contact their customers to arrange for the installation of the update. This action is a follow-up to RC-2013-RN-00397-1.
This action has been closed-out on 05/12/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Some patients have reported experiencing an uncomfortable temperature increase at the ipg implant site during charging, with a small number of patients reporting burns at the implant site. this matter is a follow-up to a hazard alert letter issued by st. jude medical (sjm) in august 2012 (tga reference: rc-2012-rn-00759-3). in the august 2012 letter, st. jude medical informed customers that they would be implementing design improvements to the charger to address the possibility of increased energy dissipation during charging. the new eon charging system model 3726 reduces the potential for uncomfortable temperature increases that may be felt near the spinal cord stimulator while recharging by automatically turning the energy it delivers on and off to reduce the rise in temperature of the spinal cord stimulator and of the charger wand during charging.
Acción
St. Jude Medical is recommending to implanting physicians for the prompt replacement of the charger for patients who have reported excessive heating during charging. For other patients, replacement of the charger is recommended at the next follow up. Upon replacement, proper charging function of the Eon Charging System Model 3726 should be confirmed. Until such time that patients have had their chargers replaced, patients should be advised to continue to use their current Eon Mini Charging System following the precautions provided in the August 2012 letter. This action has been closed-out on 09/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Some patients have reported experiencing an uncomfortable temperature increase at the ipg implant site during charging, with a small number of patients reporting burns at the implant site. this matter is a follow-up to a hazard alert letter issued by st. jude medical (sjm) in august 2012 (tga reference: rc-2012-rn-00759-3). in the august 2012 letter, st. jude medical informed customers that they would be implementing design improvements to the charger to address the possibility of increased energy dissipation during charging. the new eon mini le charging system model 3722 and eon mini le charger model 3720 reduce the potential for uncomfortable temperature increases that may be felt near the ipg while recharging by automatically turning the energy it delivers on and off. this will require patients to charge longer or more frequently to achieve a full charge.
Acción
St. Jude Medical recommends the prompt replacement of the charger for patients who have reported excessive heating during charging. For other patients, replacement of the charger is recommended at the next follow up. Upon replacement, proper charging function of the Eon Mini LE Charger Model 3720 must be confirmed. The Eon Mini LE Charging System Model 3722 and Eon Mini LE Charger 3720 may not be able to charge implanted IPGs at an implant depth greater than 2.25cm (the Model 3721 was labelled for implant depth up to 2.50cm). In case of difficulties with the charging function of the Eon Mini LE Charger Model 3720 due to the depth of the implant, patients should continue to use their current Eon Mini Charging System Model 3721 following the precautions provided in the August 2012 letter. This action has been closed-out on 04/04/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The tubing within the system that drains csf may leak or disconnect from the joints. leakage and tube separations may result in over- or under-drainage of csf from the ventricular system or introduction of air into the ventricular system (pneumocephalus). this may result in collapsed ventricles, subdural bleeding, or an inability to properly control elevated intracranial pressure. the tubing disconnection or leakage may also increase the risk of ventriculitis. if undetected or untreated each of these events may cause severe brain injury, which may lead to coma, stroke or death. these systems are most often used on neurocritical care floors and these issues are likely to be detected immediately.
Acción
Johnson & Johnson Medical Pty Ltd (JJM) is issuing a two stage recall action to mitigate the risk of shortage for these devices in the market place.
STAGE 1 - INFORM: Inform customers regarding the product issues and what actions need to be undertaken in the interim.
STAGE 2 - RECALL: Customers should return affected product to JJM once they have sourced alternate product.
In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. Manipulation of tubing should be minimised and extra vigilance (identified in the customer letter) is required for early detection of leakage and/or disconnection.
After the alternative products have been sourced by customers, affected products should be quarantined for returning it to JJM.
This action has been closed-out on 28/02/2018,
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm h2o. recent in-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm h2o. this testing found only one occurrence out of 72 test instances that was significantly below 400mm h2o (observed at 275mm h20), although when retested, this valve performed above 400mm h2o. if a valve is considered to be virtually off, but is still operating at a physiologically relevant pressure, a clinician may inaccurately consider the patient to be shunt independent. this may result in a delay in treatment for shunt-related complications. if the virtual off setting is being used to restore ventricular volume for patients with slit ventricle syndrome or subdural haemorrhage formation resulting from overdrainage, treatment response may be delayed for valves operating significantly below 400mm h2o.
Acción
Surgeons are advised that:
· no action is required if patient is experiencing good outcomes with an implanted valve
· be aware that symptoms resulting from this issue would be similar to those seen in the standard course of treatment, so it can be difficult to directly correlate complaints with this problem
· If the Virtual Off setting is being used to address an acute overdrainage situation that has resulted in subdural haemorrhage or slit ventricle formation, close observation is advised to make sure that the patient is responding as expected (operating pressure 400mm H2O).
Please note that the manufacturer, Codman Neuro is not recommending explanation of CODMAN CERTAS Valves. For more details, please see http://www.tga.gov.au/safety/alerts-device-codman-certas-valves-140729.htm This action has been closed-out on 06/06/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The patient line tubing in the affected devices may become disconnected from the patient line stopcock. investigations undertaken by medtronic determined that this issue was caused by a combination of using tubing that exceeded the recommended shelf life as well as the cleaning process of the tubing during assembly. disconnection of the patient line is more likely to occur during handling of the system by a healthcare professional.
Acción
Medtronic is advising their customers to cease use of the affected product and return any unused units. If any of the potentially affected products are in use it should be verified that the connections are secure and leak free.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Cycling is a programmable feature which allows the stimulation output of a device to toggle on and off based on programmed settings. enabling cycling at certain parameter settings may decrease the recharge interval for rechargeable devices and the device longevity.In may 2012, the first two cases of premature battery depletion where cycling was programmed at fast rates (0.1s on/off) in conjunction with low patient amplitudes (<3 volts) were reported. both of these reports involved the primeadvanced device model 37702. both devices were explanted, returned and analysed. this inspection, engineering bench testing, and detailed understanding of how the patients used these devices confirmed that specific patient therapy parameters in conjunction with cycling being enabled resulted in a higher current drain on the battery when compared to running the device in continuous mode. higher current drain results in reduced battery longevity.
Acción
Surgeons are advised that the updated calculations and graphs available at professional.medtronic.com/cycling to assess the affect of cycling on device longevity. Surgeons are requested to remind their patients to continue to check battery status. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-neurostimulation-140317.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
1) unexpected loss of stimulation may occur under the following conditions:- switching from a group with two programs to a group with three or four programs where a non-negative contact is shared within the programmed groups. - creating program groups (activa sc only) when a second program is created for the first time.2) under a specific set of conditions (activa sc – models 37602 / 37603 are not affected), typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended:- device reaches a power on reset (por) state. a por may be detected during interrogation with the patient or physician programmer. the patient will experience loss of therapy if a por occurs.- ‘therapy off’ command is sent (by patient programmer, insr, or ‘therapy-stop’ button on the 8840 clinician programmer) to device while the device is making an automatic periodic battery measurement.
Acción
Medtronic does not recommend prophylactic explant of devices because these issues can be addressed non-invasively by the clinician using an 8840 clinician programmer or an Implantable Neurostimulator Recharger using the Physician Recharge Mode. The model 8870 software application card used by the programmer is being updated to version BBR01A by Medtronic field representative. Interrogating patient’s device with the updated software version will automatically update the implanted device software and reduce the probability that a loss of stimulation output will occur. To significantly reduce the likelihood of over stimulation or stimulation in the wrong area, patients should avoid over discharge. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-deep-brain-spinal-cord-stimulation-devices-140204.htm . Thia action has been closed-out on 28/01/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic has identified that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause the look-ahead view labels to show user selected depths (displayed), but the corresponding images are shown at a depth twice the selected distance. under these conditions, visualisation of the planned trajectory could show the image at the incorrect depth. further internal investigation of similar or related views discovered that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause a similar discrepancy between the exam image and the displayed measurement or overlay. the use conditions are;- use of framelink 5.4 software on an s7, i7 or planning station system that has a rollingstone computer, and- the framelink 5.4 software configuration setting "use fillslicestackresolution" is set to true, and- the user loads a high-resolution exam for use during a surgical procedure.
Acción
Medtronic is requesting users to not use high-resolution examinations (greater than 256 x 256). A software solution will be implemented to permanently correct the issue.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Johnson & johnson testing has shown that, in a small percentage of valves, the following conditions may exist:1. the mri resistance feature may not always operate properly. if this occurs, it could potentially result in an unintended change in the valve setting due to exposure to an mri procedure or other magnetic field. based on reported complaints, this issue may have been a factor in up to 0.06% of units sold.2. the programming mechanism may not always operate properly. if this occurs, it could potentially lead to an inability to modify the operating pressure of the valve with the hand-held programming tools, also referred to as the codman certas therapy management system (tms). based on reported complaints, this issue may have been a factor in up to 0.4% of units sold.
Acción
JJM is recalling the affected units that have not been implanted. For patients that have already been implanted with the device, JJM is providing additional instructions to clinicians to identify whether the implanted device has been affected and what actions to undertake if the device has been affected. For more details, please see http://www.tga.gov.au/safety/alerts-device-codman-certas-valves-130527.htm .
This action has been closed-out on 29/01/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Brainlab has detected that, when using the brainlab cranial navigation system, the following may have a significant effect on the overall navigation accuracy:- large distance between reference array and region of interest- major changes of the camera position relative to the reference array during the procedure.
Acción
Brainlab are providing additional instructions for use regarding the correct use of the Brainlab Cranial Navigation System. End users are advised to continue to follow the instructions in the user manual and adhere to the measures documented in the additional instructions for use (Measures to Improve Cranial Navigation Accuracy).
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The production process may have deviated during the manufacture of specific lots. the product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products.
Acción
Integra is recalling the affected product and is asking clinicans to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The production process may have deviated during the manufacture of specific lots.The product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products.
Acción
Integra is recalling the affected product and is asking clinicans to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
This is a follow up action to rc-2013-rn-00124-1. medtronic issued an urgent recall for product correction to inform surgeons of the potential for the proximal end of the dbs lead to be damaged when the connector block of the dbs lead cap twists within the assembly when turning the set screw during step 1 of dbs surgery. the damage would most likely occur at lead contact number 3 which could affect electrode contact number 3. there is a 5.0 in-oz requirement on the lead cap assembly specification. recent testing indicates that this requirement is not being met.Medtronic has implemented manufacturing process changes that address the twisting of the setscrew connector block within the lead cap and is now removing any unused product that was distributed to customers prior to implementing the change.
Acción
Medtronic is advising their customers that a sales representative will organise for the return of all affected stock. Surgeons are also advised that the work around instructions described in recall RC-2013-RN-00124-1 are no longer necessary for new lots of the product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The proximal end of the dbs lead can be damaged when the connector block of the dbs lead cap twists within the assembly when turning the set screw during step 1 of dbs surgery. the damage would most likely occur at lead contact #3 which could affect electrode contact #3. there is a 5.0 in-oz requirement on the lead cap assembly specification. recent testing indicates that this requirement is not being met.
Acción
Medtronic is working on a corrective action to reduce the occurrence of setscrew connector block twisting. It is recommended that the lead cap is not used until corrective actions are implemented. If it is imperative that the operation be carried out in a two stage procedure users are required to follow modified instructions:
-Capping the Lead
Step 4 - Any time you use a torque wrench, hold the setscrew connector block firmly between thumb and forefinger to prevent rotation of the block
Step 5 - Tighten the single setscrew socket on the number 3 lead contact by turning it clockwise with the torque wrench provided. Tighten the setscrew until it touches the contact; then continue tightening for a maximum of 1/4 turn only (you may or may not hear the sound of a click).
-Removing the Lead Cap
Step 5 & 6 - Hold the setscrew connector block firmly between thumb and forefinger to prevent rotation. Failure to prevent rotation may break or damage the lead, and may require lead replacement.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
This is an update to the 'hazard alert' letter dated 24 may 2011, pertaining to the eon mini model 3788 and brio model 6788 implantable pulse generators (ipgs) inner battery cracking issues. st. jude medical received reports eon mini and brio ipgs that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant.
Acción
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please refer to the TGA Website http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm