Author + information
- Melissa Buescher,
- Lena Trager,
- Mark Horning,
- JoEllyn Moore and
- Jay Sengupta
Background: This abstract presents a series of pacemaker dependent patients who experienced unexpected high battery impedance leading to device failure of the Medtronic® InSync III Cardiac Resynchronization Therapy Pacemaker (CRT-P model 8042B) which prompted a Class II FDA recall in November 2015. The study's aim is to describe our center's recognition of patients with device failures and their outcomes. There are no published reports describing the InSync III recall and adverse events.
Methods: This was a single center retrospective study. Before a device advisory was issued, we noted a pattern of rapid battery depletion within the pacemaker dependent population implanted with the InSync III at our center. Once the FDA recall was issued, a database of subjects implanted with this device was allocated to our group. After the database was reviewed with physicians, clinic nurses and research coordinators, we started a collaborative investigator-initiated research protocol to track long-term outcomes in this patient group to develop follow-up and replacement guidelines. We extracted relevant data from the electronic medical record such as implant and explant dates, device status, battery longevity, pacemaker dependency and adverse events.
Results: There were 448 InSync III implants from 2004 to 2011, with 88 active at the time of recall, of whom 70 were pacemaker dependent. 4 (4.54%) patients experienced device failures, 2 due to high battery impedance and 2 due to faulty wire bond connectors, resulting in a loss of output on CRT-P leads. The elective replacement interval (ERI) in these cases showed inconsistent battery life and inability to capture data. Patients presented similarly, sustaining syncopal episodes prompting hospital admission. 2 required emergent replacement after it was determined that one patient's battery was entirely dead and the other exhibited failure to pace.
Conclusions: Our center experienced a higher device failure rate than what was reported globally by Medtronic®, necessitating a collaborative management protocol to track outcomes. There is a need for more studies to describe similar recalls in order to develop management strategies for patients with flawed devices.
Poster Hall, Hall C
Sunday, March 19, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Arrhythmias and Clinical EP: Devices 4
Abstract Category: 5. Arrhythmias and Clinical EP: Devices
Presentation Number: 1278-082
- 2017 American College of Cardiology Foundation