MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-03-07 for HEARTMATE RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corp..
[587014]
The pt was implanted with the manufacturer's clinical trial left ventricular assist device (lvad). It was reported by the vad coordinator, that the pt experienced a red heart alarm and subsequently the pump stopped. The pt was placed on back up batteries and the pump restarted.
Patient Sequence No: 1, Text Type: D, B5
[7922668]
A decision was made to exchange the pt to another clinical trial lvad with no further issues. The batteries were returned to the manufacturer and have been evaluated. The battery voltage was checked and confirmed to be in specification. The batteries were charged without issue and green leds were received indicating a good battery. The batteries were run on a mock circulatory loop and alarmed appropriately with yellow and then red battery as voltage decreased. The reported event that the battery caused a red heart alarm and stopped the pump was not confirmed. No further information is available at this time. The manufacturer is closing its file on this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2007-00037 |
| MDR Report Key | 824487 |
| Report Source | 05,06 |
| Date Received | 2007-03-07 |
| Date of Report | 2007-02-09 |
| Date of Event | 2007-02-09 |
| Date Facility Aware | 2007-02-09 |
| Report Date | 2007-02-09 |
| Date Reported to Mfgr | 2007-02-09 |
| Date Mfgr Received | 2007-02-09 |
| Date Added to Maude | 2007-03-09 |
| 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 | 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 | 2007-03-07 |
| Returned To Mfg | 2007-02-26 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MG172 |
| 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 | 811890 |
| Manufacturer | THORATEC CORP. |
| 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 | 2007-03-07 |