MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-17 for HEARTMATE RECHARGEABLE BATTERY 102515 manufactured by Thoratec Corp..
[4259608]
The patient was implanted with a left ventricular assist device (lvad). It was reported by the transplant coordinator that multiple power cable disconnect and red heart alarms were noted in patient history. A sign of corrosion on one of the patient's batteries was noted. The hospital replaced the patient's batteries and battery clips. Additional information was received 6 days later indicating that with the change of batteries and battery clips, no alarms were occurring.
Patient Sequence No: 1, Text Type: D, B5
[11604980]
The patient remains on going with the implanted device and no further issues have been reported. No further information is available at this time. The manufacturer was advised that the product will not be returned for 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 | 2916596-2013-01667 |
| MDR Report Key | 3694589 |
| Report Source | 05,06 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-11-19 |
| Date of Event | 2013-11-19 |
| Date Facility Aware | 2013-11-19 |
| Report Date | 2013-11-19 |
| Date Reported to Mfgr | 2013-11-19 |
| Date Mfgr Received | 2013-11-19 |
| Date Added to Maude | 2014-04-15 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR 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 BATTERY |
| Generic Name | RECHARGEABLE BATTERY |
| Product Code | MOY |
| Date Received | 2013-12-17 |
| Model Number | 102515 |
| Catalog Number | 102515 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2013-12-17 |