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 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
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
Medtronic has identified the potential for an issue with all mindframe capture lp devices to partially detach or separate from the delivery wire.
Acción
For affected product that has not been used, Medtronic is advising users to quarantine all unused affected product to prevent further use and return them. A Medtronic representative can assist in facilitating the return of product as necessary.
In situations where the MindFrame Capture LP device stent or stent fragments have been retained, Medtronic is unable to provide specific patient management recommendations at this time due to patient variability associated with these situations. Medtronic is investigating if recommendations can be made to mitigate potential risks associated with this situation and will contact users as soon as possible when these recommendations, if any, become available.
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
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
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
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 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
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
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
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.
Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.