MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-06 for HEARTMATE 12 VOLT SLA BATTERY SET 2025 manufactured by Thoratec Corp..
[1522558]
The patient was implanted with a left ventricular assist device (lvad). The perfusionist reported that the patient and his wife fell asleep at home while the patient was on battery support. The patient's wife was awakened by the system controller alarming for battery power. The patient was reportedly unresponsive with one battery clip attached and no power sources engaged. Emergency medical services (ems) was called, and in the mean time the spouse was instructed by the hospital to connect patient to the power base unit and to exchange the batteries. The patient was taken to the emergency room (er). While in the hospital, it was observed that the system controller had bent pins; the hospital suspected that the bent pins may have been as a result of the spouse's attempt to change power sources and not a device malfunction resulting to the reported event. Per the family's request, the patient's support was withdrawn due to significant cerebral injury and unresponsiveness. Additional information provided to the manufacturer indicates that the patient had been warned several times about letting the batteries drain too far.
Patient Sequence No: 1, Text Type: D, B5
[8596457]
The manufacturer is attempting to acquire the devices in use on the patient at the time of the event for further evaluation. No further information is available at this time. A supplemental report will be submitted when the manufacturer's investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2010-00074 |
| MDR Report Key | 1652835 |
| Report Source | 05,06 |
| Date Received | 2010-04-06 |
| Date of Report | 2010-03-08 |
| Date of Event | 2010-03-08 |
| Date Facility Aware | 2010-03-08 |
| Report Date | 2010-03-08 |
| Date Reported to Mfgr | 2010-03-08 |
| Date Mfgr Received | 2010-03-08 |
| Date Added to Maude | 2010-04-09 |
| 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 AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812720139 |
| Manufacturer G1 | THORATEC CORP. |
| Manufacturer Street | 6035 STONERIDGE DR. |
| 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 12 VOLT SLA BATTERY SET |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2010-04-06 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORP. |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-04-06 |