MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-05-05 for HEARTPAK RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corporation.
[17867928]
The patient was implanted with a left ventricular assist device (lvad). The study coordinator reported that the patient was found at home, unconscious on the floor with audible alarms and neither of the two batteries were fully engaged. Emergency medical services (ems) was called, the batteries were re-connected and the patient was taken to the hospital and admitted for observation. Per the study coordinator, none of the components had failed; the reported event appeared to have been most probably due to patient error.
Patient Sequence No: 1, Text Type: D, B5
[18013256]
The patient was discharged home and remains ongoing on lvad support with no further issues reported. 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 | 2916596-2009-00091 |
| MDR Report Key | 1375457 |
| Report Source | 05,06 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-04-09 |
| Date of Event | 2009-04-08 |
| Date Facility Aware | 2009-04-08 |
| Report Date | 2009-04-09 |
| Date Reported to Mfgr | 2009-04-09 |
| Date Mfgr Received | 2009-04-09 |
| Date Added to Maude | 2009-05-11 |
| 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 AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812720139 |
| 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 | HEARTPAK RECHARGEABLE BATTERIES |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2009-05-05 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-05 |