MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-21 for HEARTMATE RECHARGABLE BATTERIES 2025 manufactured by Thoratec Corporation.
[17023572]
The patient was implanted with a vented electric left ventricular assist device (lvad). It was reported by the lvas supervisor that the pt disconnected the black lead to switch from power base unit to battery support. Subsequently, the white lead was disconnected, and at this time the battery life depleted and the pump stopped within 15-30 seconds. The hospital initially troubleshoot by changing the white lead and the system controller. However, these actions produced the same alarms. Another set of batteries was then used, without further incidents.
Patient Sequence No: 1, Text Type: D, B5
[17231022]
The pt remains on lvad support. The batteries were returned to the manufacturer, and are currently being analyzed. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2006-00130 |
| MDR Report Key | 752337 |
| Date Received | 2006-08-21 |
| Date of Report | 2006-07-21 |
| Date of Event | 2006-07-21 |
| Date Facility Aware | 2006-07-21 |
| Report Date | 2006-07-21 |
| Date Reported to Mfgr | 2006-07-21 |
| Date Mfgr Received | 2006-07-21 |
| Date Added to Maude | 2006-08-22 |
| 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 | 23 FOURTH AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812720139 |
| 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 RECHARGABLE BATTERIES |
| Generic Name | RECHARGABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2006-08-21 |
| Returned To Mfg | 2006-07-20 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MG104010 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 740127 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | * PLEASANTON CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-21 |