HEARTMATE 3 LVAS IMPLANT KIT Adverse Event — Malfunction (MDR 2916596-2020-02034)
HEARTMATE 3 LVAS IMPLANT KIT Adverse Event — Malfunction (MDR 2916596-2020-02034) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE 3 LVAS IMPLANT KIT; Generic name: VENTRICULAR (ASSISST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE 3 LVAS IMPLANT KIT |
|---|---|
| Generic name | VENTRICULAR (ASSISST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 2916596-2020-02034 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | SECTION H4: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSIONS: THE REPORT OF DAMAGE TO THE OUTER JACKET OF THE PUMP CABLE WAS CONFIRMED VIA THE SUBMITTED PHOTOGRAPHS. A SPECIFIC CAUSE FOR THE OBSERVED DAMAGE COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THERE WERE NO ALARMS OR ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVA |
| Source | openFDA MAUDE (device adverse events) |
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