MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2006-09-20 for HEARTMATE RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corp..
[538700]
The patient was implanted with the manufacturer's clinical trial left ventricular assist device (lvad). It was reported by the perfusionist, that while eating lunch in the rehab hospital, the patient experienced a yellow battery alarm. The patient proceeded to exchange the batteries, and as he disconnected the first battery, the system controller alarmed with red battery and red heart alarms. The patient exchanged the batteries; however, the alarms persisted. He decided to return to his room to switch back to his own power base unit (pbu). It was further reported, that while walking back to his room, the patient felt weaker and was then found unconscious by a physician. The physician exchanged the batteries and brought the patient to icu and connected him to the pbu. The patient became responsive and was kept in the icu for a few hours for monitoring. Later that day, the patient was brought back to his room.
Patient Sequence No: 1, Text Type: D, B5
[7795441]
The manufacturer is attempting to acquire the batteries for further evaluation. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2006-00176 |
| MDR Report Key | 768799 |
| Report Source | 01,05,06 |
| Date Received | 2006-09-20 |
| Date of Report | 2006-09-20 |
| Date of Event | 2006-09-18 |
| Date Facility Aware | 2006-09-18 |
| Report Date | 2006-09-20 |
| Date Reported to Mfgr | 2006-09-20 |
| Date Mfgr Received | 2006-09-20 |
| Date Added to Maude | 2006-10-13 |
| 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 RECHARGEABLE BATTERIES |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2006-09-20 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MG172 |
| 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 | 756653 |
| Manufacturer | THORATEC CORP. |
| Manufacturer Address | * PLEASANTON CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-20 |