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
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
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 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
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
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
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
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
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
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.
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.
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.
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.