MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-01-19 for HEARTMATE RECHARGABLE BATTERY 2025 manufactured by Thoratec Corporation.
[395210]
The patient was implanted with a vented electric left venticular assist device (lvad). It was reported by the vad coordinator that the patient was at home, and had either used a pair of 'bad batteries' or inserted them incorrectly. Ti was reported that the device alarmed and 911 was called; however, the patient was unconscious for several minutes by the time ems had arrived to the home. New batteries were inserted by ems and the pump started appropiately. The patient was then intubated. Ems also reported asystole on the monitor then vf, which patient's icd shocked him out of then paced rhythm of 78. The patient was then given 1 amp of epinepherine down the et tube at patient's home. The ems was informed by vad coordinator that if they provided cpr it could dislodge the outflow graft to the vad. The vad coordinator remained on the line with medics during transport to the hospital. The medics gave another 1/2 amp of epinepherine; repeated and gave approximately 1 minute of 'gentle' chest compressions which gave the patient a heart rate of 120 (reported as wide complex) but still the patient was unresponsive. The medics also reported 'agonal' respirations at the rate of 2-3 over a minute. The patient arrived to the hospital intubated, and still unresponsive. The patient presently remains on vent support and unconscious in the icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2006-00008 |
| MDR Report Key | 665558 |
| Report Source | 05,06 |
| Date Received | 2006-01-19 |
| Date of Report | 2005-12-20 |
| Date of Event | 2005-12-19 |
| Date Facility Aware | 2005-12-19 |
| Report Date | 2005-12-20 |
| Date Reported to Mfgr | 2005-12-20 |
| Date Mfgr Received | 2005-12-20 |
| Date Added to Maude | 2006-01-23 |
| 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 | PLEASNATON 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 RECHARGABLE BATTERY |
| Generic Name | RECHARGABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2006-01-19 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 654937 |
| Manufacturer | THORATEC CORPORATION |
| 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 | 2006-01-19 |