Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a withdrawal of product by Medtronic. The users concerned received the attached mail (19/03/2018) (184 KB). This safety action is registered at ANSM under the number R1804654.
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.
Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 data from the U.S. and Italy.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Medtronic security note (FA848) for StealthStationTM Cranial and SynergyTM Cranial software
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
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 certain clip gun magazines have failed to meet the requirement of post-sterile seal integrity. testing performed by medtronic showed that the packaging sterile barrier of the pmc manufactured magazine cm8902, does not comply with the applicable packaging standard for terminally sterilised medical devices.Whilst the instructions for use (ifu) state “do not use if package has been previously opened or damaged”, it is possible that the seal breach may go undetected by the users’ naked eye. to date, medtronic has not received any complaints related to a sterile breach or infection that could potentially be related to a sterile breach.
Acción
Medtronic is advising customers to identify affected product and return any unused units to Medtronic. Instructions for return can be found in the Customer Confirmation Form provided with the Customer Letter.
Clinicians and their Patients who may have received the listed devices should monitor the patient’s condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection.
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
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
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 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
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).