MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-30 for HEARTMATE RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corp..
[1747218]
The pt was implanted with a left ventricular assist device (lvad). The vad coordinator reported that the pt had experienced red heart alarms when changing his batteries. It was also reported that the batteries were not lasting as long as usual, and the pt had a few power spikes and one low speed operation. The pt felt good. The pt's waveform was reviewed by the manufacturer and the runtime parameters were within normal limits. The system controller log file was also reviewed and there were power saver mode events recorded which were caused by low battery hazards. There was also one event recorded where there was loss of power to the system controller, resulting in the pump speed to drop to zero. The pt's batteries were exchanged without incident. The batteries with lot numbers mi196251 (exp june 2011), mj211318 (exp july 2012), mj225008 (exp july 2012), mj225288 (exp july 2012), mj225339 (exp july 2012), mj225390 (exp july 2012), mj225404 (exp july 2012), mj225520 (exp july 2012), mj225594 (exp july 2012), mj225604 (exp july 2012), mj225610 (exp july 2012), were returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[8807540]
The batteries were returned to the manufacturer for analysis. During functional testing, it was found that some of the batteries (lot numbers mi196251, mj211318, mj225339, mj225390, mj225404, and mj225520) did not meet the expected support time per specifications in the operating manual. These batteries lasted one to two hours until the yellow battery alarmed. However, the manufacturer was unable to reproduce the reported red heart alarm, power spikes, or the low speed, even when the batteries were disconnected from the system controller. The manufacturer's operating manual contains the following caution statement regarding sla batteries: "the batteries should be routinely replaced when a marked reduction in operating time is detected (about twice per year). " no further information is available. The manufacturer is closing its file on this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2010-00318 |
| MDR Report Key | 1931995 |
| Report Source | 05,06 |
| Date Received | 2010-11-30 |
| Date of Report | 2010-11-02 |
| Date of Event | 2010-11-02 |
| Date Facility Aware | 2010-11-02 |
| Report Date | 2010-11-02 |
| Date Reported to Mfgr | 2010-11-02 |
| Date Mfgr Received | 2010-11-02 |
| Date Added to Maude | 2011-04-25 |
| 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 RECHARGEABLE BATTERIES |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2010-11-30 |
| Returned To Mfg | 2010-11-09 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MI196251 |
| ID Number | NA |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Other | 2010-11-30 |