HEARTMATE 3¿ Adverse Event — Injury (MDR 10004847)
HEARTMATE 3¿ Adverse Event — Injury (MDR 10004847) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE 3¿; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE 3¿ |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 10004847 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Narrative | HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) PRESENTS WITH EXTENSIVE MSSE DRIVELINE INFECTION REQUIRING SURGICAL INCISION AND DRAINAGE OF THE DRIVELINE TRACT WITH UNROOFING AND REPOSITIONING OF THE DRIVELINE, VACUUM DRESSING, IV ANTIBIOTICS, AND HIGHER STATUS UPGRADE FOR HEART TRANSPLANT. |
| Source | openFDA MAUDE (device adverse events) |
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