Device product
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Z-2071-2019
Product summary
- Event
- Event 83252
- Status
- Terminated
- Classification
- Class I
- Quantity
- 47
- Official record key
device-enforcement:Z-2071-2019
Official wording
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Code information: Serial Number: 1281828, 1281840, 1282688, 1282724, 1282734, 1283113, 1283627, 1283633, 1283634, 1283639, 1283641, 1283643, 1283646, 1283648, 1283656, 1283657, 1283659, 1283660, 1283672, 1283680, 1283681, 1283683, 1283689, 1283690, 1283692, 1283695, 1283697, 1283703, 1283704, 1283708, 1283742, 1283747, 1283749, 1283766, 1283772, 1283780, 1283783, 1283784, 1283788, 1283832, 1283838, 1283845, 1283868, 1283884, 9831441, 9831445, 9831759
Distribution pattern: Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO
Derived failure modes
-
Unknown
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.