HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE Adverse Event — Injury (MDR 3007042319-2020-02997)
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE Adverse Event — Injury (MDR 3007042319-2020-02997) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: HEARTWARE, INC..
| Device | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE |
|---|---|
| Generic name | VENTRICULAR (ASSIST) BYPASS |
| Manufacturer | HEARTWARE, INC. |
| Report number | 3007042319-2020-02997 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, STUDY |
| Narrative | A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. INVESTIGATION OF THIS EVENT IS COMPLETED, AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED, AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MED |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →