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
A software anomaly has been identified in the merlin@home system that also has the potential to cause software resets for st. jude medical devices. despite the previous software upgrade, a low incidence of back up operation in some implanted st. jude medical devices with radio-frequency (rf) capability has been observed. this may occur as a result of a merlin@home transmitter initiating an implanted device software reset.This issue can only occur when the patient is being actively monitored by a merlin@home rf bedside transmitter.
Acción
Surgeons are advised that the majority of ICD and pacemaker devices are non-invasively restored by St. Jude Medical Technical Support over the air. However, in rare cases the device is unable to be restored and replacement may be required. St. Jude Medical has refined the software download procedure to reduce the incidence of failure.
In the event a patient’s device reverts to back-up mode, St Jude Medical Australia recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality.
The Merlin@home transmitter software will be updated to prevent this issue from occurring. The software update will be performed automatically over the telephone, broadband or cellular connection .
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
St. jude medical has become aware of a small number of optisure dual coil defibrillation leads that may have had potential insulation damage at the interface of the termination sleeve and svc shock coil in optisure dual coil defibrillation leads. this damage has been determined to have occurred during the manufacturing process.In the event that a subject optisure lead is connected to a device without dynamic tx technology, there is the potential for lead damage to result in loss of defibrillation therapy during attempted shock delivery when programmed to the rv to svc and can high voltage therapy configurationst. jude medical is not aware of any complaints or clinical incidents related to this matter.
Acción
Customers are asked to quarantine all unused units prior to return to St Jude Medical. For affected units that have been implanted, St Jude Medical is advising that patients should continue to be managed in accordance with the patient management protocol included in the customer letter. For further information, please see http://www.tga.gov.au/alert/optisure-dual-coil-defibrillation-leads This action has been closed-out on 22/08/2016.
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
St. jude medical (sjm) is notifying physicians of the risk of premature battery depletion associated with their icds and crt-ds manufactured before may 23, 2015. high voltage icds and crt-ds that utilise lithium-based battery chemistries are subject to lithium cluster formation during high voltage charging. depending on their location, lithium clusters may cause a short circuit that can lead to premature battery depletion. if a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy.Among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. forty-six (46) exhibited visible clusters bridging the cathode and anode causing shorting. there have been 2 deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion.
Acción
SJM is contacting physicians to provide details regarding risk and patient management recommendations. Premature battery depletion can be identified by physicians through remote monitoring or in person visits showing ERI or more advanced battery depletion.Patients may become aware when their device reaches ERI because they may feel a vibratory patient notifier alert.SJM is providing recommendations that include confirming patients can feel and recognise vibratory alerts and reaffirming the availability and usage of remote monitoring to avoid or minimise time without device therapy for bradycardia and tachycardia events. Prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion. SJM is also notifying doctors not to implant any unused affected devices that they may have in their inventory.These devices will be replaced by unaffected stock. This action has been closed-out on 17/05/2017.
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
St. jude medical has identified that in rare cases devices with radio frequency (rf) communication capability can revert to backup operation settings this issue can occur as a result of a merlin@home transmitter initiating an implanted device software reset. this issue can only occur while the patient is being actively monitored by a merlin@home rf bedside transmitter.
Acción
The Merlin@home software will be updated to prevent this issue from occurring. The software update will be performed automatically over the telephone, broadband or cellular connection.
Surgeons are advised that the majority of ICD and pacemaker devices are non-invasively restored by St. Jude Medical Technical Support over the air. However, in rare cases the device is unable to be restored and replacement may be required. St. Jude Medical has refined the software download procedure to reduce the incidence of failure.
Further information will be published on the TGA web site at - http://www.tga.gov.au/current-year-alerts
This action has been closed-out on 14/07/2016.
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
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
Boston scientific has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer’s pacing lead system, but boston scientific has determined it to be more likely for affected boston scientific pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
Acción
A software upgrade is being developed for distribution in early 2018. Until this is available to automatically resolve MV sensor signal oversensing, Boston Scientific recommends managing the risk for patients implanted with affected systems as follows:
·Subject to the the guidance supplied to customers, turn the MV sensor to “OFF”
·If transient, abrupt changes or any out-of-range RA/RV pacing impedance measurements are observed, contact Boston Scientific Technical Services to explore all non-invasive programming options prior to surgical intervention
·For patients with the MV sensor enabled, periodically re-assess for pacemaker dependence
Doctors are encouraged to
·Enroll and follow patients using the LATITUDE NXT Remote Patient Management System
·Provide the supplied patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is 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
The product and product label on the inner pouch do not match the outer product label. the product listed on the inner pouch is correct. use of the affected unit may result in a procedural delay while another occluder of the desired size is obtained.
Acción
St. Jude Medical sales representative will contact customers to facilitate removal of the affected product and for providing replacement or issuance of full credit for the removed 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
When using the merlin programmer with software version17.2.2 as part of a single vf detection zone configuration for icd/crt-d devices, the sinus redetection value will be inappropriately set to zero milliseconds. as a result, any intrinsic activity following the first shock will be considered a “sinus rate” and the device will diagnose “return to sinus”. therefore, if the arrhythmia was not terminated by the initial high voltage therapy, the ongoing arrhythmia would be considered a new episode causing the next high voltage therapy to also be delivered at the first programmed energy level. for example, if the first shock is programmed to 20 joules and subsequent shocks are programmed to higher energy values, the only hv therapy the patient would receive if the arrhythmia continues and is redetected, would be 20 joules, rather than the increasing hv energy levels as programmed.
Acción
Clinicians are advised to review their SJM ICD/CRT-D patient records for patients with affected devices implanted or seen in clinic starting in September 2013 and programmed to a single VF detection zone with the 17.2.2 software. For patients identified during this review St. Jude is recommending to immediately schedule a follow-up visit. For patient devices programmed with 17.2.2 software, a new software version 17.2.3 will correct this issue and is expected to be available by February 2014. Using this software, programming any parameter will reset the return to sinus criteria to normal function. If a patient is seen before the 17.2.3 software is installed, then program the device to a two or three zone configuration, even if one of the zones is strictly a monitor zone. This will resolve the issue when using a programmer with 17.2.2 software. For more details, please see http://www.tga.gov.au/safety/alerts-device-st-jude-medical-icd-crtd-140128.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
St. jude medical (sjm) has received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value. this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock. there have been no reported cases of an ellipse device failing to deliver high voltage therapy to a patient when needed.
Acción
St. Jude Medical is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with affected devices. Device replacement is not recommended for an Ellipse device exhibiting normal charge times, and patients should continue to be followed at routine follow-up intervals.
Surgeons are advised not to use any Ellipse devices which may be on their shelves. St. Jude Medical is advising customers that the affected stock will be retrieved and replaced by new Ellipse ICDs with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole. Ellipse ICDs with serial numbers beginning with the number “1” and starting at 1132470, as well as Ellipse ICDs with serial numbers beginning with the number “7” and starting with 7126267 incorporate the new capacitors and therefore, no affected. This action has been closed-out on 03/02/2017.
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
Reports of heating at the ipg implantation site during charging of the spinal cord and deep brain stimulators. this is an update to the 'hazard alert' letter dated 05 january 2012 . in the updated letter, st. jude is providing updated occurrence rates, informing hospitals and treating clinicians of four instances of patient burns associated with charging the ipgs and additional patient management recommendations.
Acción
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please see 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
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
St. jude medical's (sjm) data shows that two specific lots of batteries used to power the dm2100a activators may exhibit faster than normal battery depletion. dm2100a activators with batteries from affected lots may exhibit faster than normal low battery status, identified by emitting one low-pitched audible tone and flashing red lights for 9-10 seconds once every hour, or immediately when a button is pressed. additionally, in the event that an activator button is pressed and there is no indication of lights or tones, this is an indication of a depleted battery.
Acción
If an activator exhibits any of the above referenced issues, consumers and clinicians are asked to notify their local St. Jude Medical representative and the representative will provide a replacement activator at no cost.
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 indication for st. jude medical’s (sjm) occipital nerve stimulation (ons) therapy for the treatment of intractable chronic migraine is being removed from the product instructions for use. the post market clinical follow up data was not appropriate to demonstrate that the benefit of the therapy outweighs the risk at this time. st. jude medical has advised doctors not to use the eon, eon c, eon mini and prodigy scs devices and associated programmers, as well as the octrode and quattrode leads, for the purpose of occipital nerve stimulation. please note that these products are still available for use as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
Acción
St. Jude Medical has undertaken this action not following the Uniform Recall Procedure for Therapeutic Goods (URPTG) since they have classified this as a product notification.
The TGA has classified this change as a hazard alert to inform consumers and health professionals of the changed advice relating to St Jude Medical’s occipital nerve stimulation devices and the latest data relating to their use.
Regarding patients who have already been treated for ONS therapy, St Jude Medical is not recommending a change in the way currently implanted patients are followed up.
For more information, please see http://www.tga.gov.au/alert/st-jude-medical-implantable-neurostimulators-and-accessories-various-devices .
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
St. jude medical (sjm) has identified the potential for the failure of the generator and remote control to properly respond to key presses resulting in unexpected energy delivery or the inability to discontinue energy delivery with the start/ stop button. the buttons on the console and/ or remote may malfunction when the indiff connector or the remote control connector on the console of an impacted generator receives an electrostatic discharge (esd).
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
This recall has been initiated due to reports of lost telemetry and pacing output as a result of a battery malfunction associated with st. jude medical (sjm) nanostim leadless cardiac pacemaker (lcp) devices model number s1dlcp. no patient injuries have been reported in association with the loss of bradycardia pacing therapy.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
St. jude medical's post market surveillance system identified a low incidence of merlin@home transmitters initiating a software reset backup operation in some implanted st. jude medical devices with radio frequency (rf) capability. potentially affected rf devices include all models of the st. jude medical ellipsetm fortify assuratm implantable cardioverter defibrillators (icds) unify assuratm quadra assuratm crtd's and assuritytm pacemakers including assurityt mri and alluretm.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Since august 2009 smiths medical has received a total of 3 complaints regarding the introducer sheath and the introducer opening being too small for the width of the catheter experienced with port-a-cath and port-a-cath ii implantable venous and arterial access systems and introducer sets. there have been no reports of patient injury or death associated with this issue. investigation of this issue has identified the root cause to be related to the incorrect size introducer being used in several lots of finished goods. an in-depth investigation concluded that the incorrect introducer size was limited to 1 component part (from st. jude medical) which were put into production of 36 smiths medical finished goods lot numbers.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
St. jude medical (sjm) has identified the potential for the rare occurrence of neurological deficit adverse events such as autonomic symptoms pain (manifesting itself as chest or abdominal pain) or paralysis associated with implanting the paddle leads listed above.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
St. jude medical has identified a risk of premature battery depletion associated with certain st. jude medical icd and crt-d devices manufactured before may 23 2015. there is evidence of lithium material in the form of "clusters" in the battery. some devices exhibited visible clusters bridging the cathode and anode causing shorting. lithium cluster formation is a known phenomenon with this type of battery.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Although the probability is small (approximately 1 in 1000) that an error 5 occurs in your system, abbott wants to replace your cardiomems ™ patient system as soon as possible.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
As part of abbott's post-marketing monitoring and monitoring processes for clinical trials, we pointed to detachment of docking buttons after implantation or during removal attempts of nanostim leadless cardiac pacemakers (lcp), model number s1dlcp.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
With this approval, we will be able to restart nanostim implants within the leadless observational study at selected sites upon approval of the amended protocol by local ethics committees,.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
St. jude medical, a subsidiary of abbott laboratories, has recently received ce approval in the european union for the latest cybersecurity updates for its merlin @ home ™ transmitter for patients and the merlin.Net ™ remote monitoring system.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory 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 recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.St Jude Medical issued a FSN dated 19 August 2014 (340Kb), describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.Affected devices have in most cases ‘recovered’ and perform normally after an extended charge timeout. From bench testing of returned devices, the manufacturer has confirmed that the likelihood of the ICD continuing to perform normally after an extended charge timeout is far greater among those ICDs with capacitors manufactured since a process improvement at the start of August 2012 (93% recovery), compared to those manufactured before (50% recovery).St Jude Medical will be able to provide advice for ICDs exhibiting extended charge times on whether the device incorporates the earlier or later more reliable capacitors. Subsequent automated or manual capacitor testing should also help demonstrate whether there is a persistent problem following an initial timeout event. In-clinic testing and reducing the capacitor maintenance interval to every 4 months (from the standard 6-monthly interval) will enable earlier detection of a possible problem, but it is important to be aware that their combined effect will reduce the remaining device longevity by almost 20%. Clinicians should take this into account in their management of individual patients.Any device that has experienced repeated, extended charge timeout warnings should be considered for replacement. Prophylactic explant is not generally recommended, but may need to be considered in exceptional circumstances such as for very high-risk patients, or those unable to cope with the psychological effects of this issue.
Causa
(st jude medical) these defibrillators can delay or reduce the therapy that can be delivered by the icd.(mda/2014/035).
Acción
Identify affected ICDs, and if any unimplanted devices are found these should be returned to St Jude Medical, as detailed in their FSN dated 19 August 2014 (340Kb).
Identify affected patients and schedule them for a follow-up evaluation within 3 months to discuss this issue, giving priority to high-risk patients.
Interrogate the ICD and perform a manual capacitor maintenance charge, noting the time to reach full charge.
Contact St. Jude Medical’s technical support for further advice if the charge time exceeds 15 seconds or if an alert for ‘capacitor charge time limit reached’ is triggered. Consider replacing ICDs that have experienced repeated, extended charge timeout warnings.
Ensure that appropriate vibratory alarms are enabled. Test the patient’s sensitivity to the alarm and remind them to contact their clinic immediately if it is triggered, as this could be due to a capacitor charge timeout.
Ensure that Merlin remote monitoring is in place wherever possible and that remote monitoring alarms are enabled.
Reduce the ICD’s automatic capacitor maintenance interval by reprogramming to every 4 months.
Repeat the above patient review at normal follow-up intervals.