HEARTMATE II Adverse Event — Malfunction (MDR 10004845)
HEARTMATE II Adverse Event — Malfunction (MDR 10004845) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE II; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE II |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 10004845 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | HEARTMATE 2 LVAD PRESENTS WITH PUMP STOPS SUGGESTIVE OF DRIVELINE FRACTURE ON (B)(6) 2016. UNDERWENT FAILED ATTEMPT AT SPLICE REPAIR OF THE EXTERNAL DRIVELINE BY ABBOTT TECHNICIANS ON (B)(6) 2016, REQUIRING URGENT HEARTMATE 2 TO HEARTMATE 2 EXCHANGE VIA THORACOTOMY APPROACH ON (B)(6) 2016. |
| Source | openFDA MAUDE (device adverse events) |
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