U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these quicksite and quickflex leads.
Acción
A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774.
A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals.
A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these quicksite and quickflex leads.
Acción
A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774.
A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals.
A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Some devices exhibit backup vvi operation due to a backup reset.
Acción
The notification material is in the form of a Physician Letter was delivered to physicians by FedEx overnight service. The mailing went out on August 17, 2015 for receipt on August 18, 2015.
The firm's notification letter identifies clinical implications.
Clinical Implications
In the event that an Ellipse, Fortify Assura, Unify Assura, or Quadra Assura ICD enters the back-up safety mode, the nominal operational settings will be VVI pacing mode, 67 ppm, 5.0v/0.6ms with bipolar pacing output and defibrillation settings of aVF detection rate of 146 bpm and 36J high voltage therapy. In the event an Assurity or Allure pacemaker enters backup mode, it will have output settings of VVI pacing mode, 67 ppm, 5.0v/0.6ms with unipolar pacing.
This anomaly can only occur when the patient is being actively monitored by a Merlin@home bedside transmitter. If a device enters backup mode, the ICD will deliver a patient vibratory alert and the pacemaker will deliver a patient audible alert. If backup operation is encountered, St. Jude Medical Technical Services (1-800-722-3774) can assist with non-invasively restoring the device to normal operation.
The firm's notification also idenfities recommendations and mitigations.
Recommendations and Mitigations
Once available, a Merlin@home transmitter software update will be performed automatically over its telephone, broadband or cellular connection without requiring any action from you or your patients. No changes to the patients remote or in-clinic follow up schedules are required. In the event a patients device reverts to back-up mode, the firm recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality.
If you have any questions or concerns contact the local St. Jude Medical representative or St. Jude Medical's Technical Services Department.