MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-05 for HEARTMATE RECHARGEABLE BATTERY 102515 manufactured by Thoratec Corp..
[17292418]
The patient was implanted with a left ventricular assist device (lvad). It was reported by the transplant tech/coordinator that the patient's cp-worker/friend heard a steady tone alarm and went to patient's location. The patient was found trying to change his system controller. The co-worker/friend left to call 911. The transplant coordinator was unsure of any other events until she spoke with emergency medical services and did not hear an alarm in the background. The patient had a red battery alarm in the local emergency room. The patient's significant other was present with fresh batteries and replaced alarming batteries. It was noted that the patient was injured as a result of loss of power. The true nature od the event has not been determined, but the vad coordinator suspects the batteries may not have been fully charged and it is not conclusive.
Patient Sequence No: 1, Text Type: D, B5
[17497900]
The device was returned to the manufacturer for evaluation and is currently being analyzed. No further information is available at this time. A supplemental report will be submitted when the device analysis is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2014-00906 |
| MDR Report Key | 3874010 |
| Report Source | 05,06 |
| Date Received | 2014-06-05 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-05-05 |
| Date Facility Aware | 2014-05-05 |
| Report Date | 2014-05-07 |
| Date Reported to Mfgr | 2014-05-07 |
| Date Mfgr Received | 2014-05-07 |
| Date Added to Maude | 2014-06-17 |
| 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 | 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 | 2014-06-05 |
| Returned To Mfg | 2014-05-09 |
| Model Number | 102515 |
| Catalog Number | 102515 |
| ID Number | NA |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 29 MO |
| 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 | 2014-06-05 |