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
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