HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Adverse Event — Injury (MDR 2916596-2020-02122)
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Adverse Event — Injury (MDR 2916596-2020-02122) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; Generic name: VENTRICULAR (ASSISST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
|---|---|
| Generic name | VENTRICULAR (ASSISST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 2916596-2020-02122 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, STUDY |
| Narrative | SECTION H4: CORRECTED DATA MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED EPISODES OF DIZZINESS AND SYNCOPE. THE PATIENT HAD A RIGHT HEART CATHETERIZATION WITH RAMP STUDY AND WAS FOUND |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →