MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-01-09 for HEARTMATE RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corporation.
[584624]
The patient was implanted with a left ventricular assist device (lvad). It was reported by the vad coordinator that the patient was experiencing a red battery alarm. The patient switched to back up batteries and system controller, but the alarm persisted. The patient was placed on power base unit at the center and issued new batteries, which alleviated the red battery alarm. Upon review of the system controller log file, it was noted that the pump had stopped two times after the original event. The patient stated that on one occasion, he failed to completely insert a battery into the battery clip; however, he was unable to recall a second pump stoppage.
Patient Sequence No: 1, Text Type: D, B5
[7943390]
The manufacturer was unable to determine the exact cause of the reported event bacause the batteries were not returned for evaluation. The patient remains stable on lvad support without further issues. No further information is available. The manufacturer is closing its file on this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2007-00027 |
| MDR Report Key | 819248 |
| Report Source | 05,06 |
| Date Received | 2007-01-09 |
| Date of Report | 2007-01-09 |
| Date of Event | 2006-12-22 |
| Date Facility Aware | 2007-01-09 |
| Report Date | 2007-01-09 |
| Date Reported to Mfgr | 2007-01-09 |
| Date Mfgr Received | 2007-01-09 |
| Date Added to Maude | 2007-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9258478600 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE RECHARGEABLE BATTERIES |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2007-01-09 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 806737 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | * PLEASANTON CA * US |
| Baseline Brand Name | HEARTMATE RECHARGABLE BATTERY |
| Baseline Generic Name | RECHARGABLE BATTERIES |
| Baseline Model No | 2025 |
| Baseline Catalog No | 2025 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-09 |