HEARTMATE 3¿ Adverse Event — Injury (MDR 10005594)
HEARTMATE 3¿ Adverse Event — Injury (MDR 10005594) 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 | 10005594 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | RECENT HEARTMATE II TO HEARTMATE 3 EXCHANGE FOR DRIVELINE FRACTURE. PATIENT WAS DISCHARGED HOME ON 2 WEEKS LATER WITH INTERNATIONAL NORMALIZED RATIO (INR) 2.2 AND ASPIRIN 81 MG DAILY. PATIENT REPRESENTED TWO WEEKS LATER WITH SIGNIFICANT HEART FAILURE SYMPTOMS INCLUDING GROSS VOLUME OVERLOAD, THAT WERE REFRACTORY TO AGGRESSIVE MEDICAL MANAGEMENT. HIS INR ON ADMISSION WAS 5.2 WITH LACTATE 4.2. AFTER |
| Source | openFDA MAUDE (device adverse events) |
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