MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-13 for HEARTMATE RECHARGEABLE BATTERY 102515 manufactured by Thoratec Corp..
[4644605]
The patient was implanted with a left ventricular assist device (lvad). It was reported by the physician that the patient went to the emergency room due to a message "clock not set" displayed on his system controller. The patient stated that he fell asleep the night before a approximately 11:00pm and did not wake up until 1:00pm the next day. When the patient woke up, he stated that the batteries were dead and the pump was "off". He exchanged the batteries and the pump started. When interrogating the history, the physician saw "low voltage" advisories starting at 4:02am. The patient was asymptomatic. The physician was instructed on resyncing the date/time to the system controller and the alarm cleared. It was also suggested by the clinical consultant that a heparin gtts be started due to the undetermined amount of time the pump may have been off.
Patient Sequence No: 1, Text Type: D, B5
[11975975]
The manufacturer is attempting to acquire the device for further 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 | 2916596-2014-00993 |
| MDR Report Key | 3950795 |
| Report Source | 05,06 |
| Date Received | 2014-06-13 |
| Date of Report | 2014-05-17 |
| Date of Event | 2014-05-17 |
| Date Facility Aware | 2014-05-17 |
| Report Date | 2014-05-17 |
| Date Reported to Mfgr | 2014-05-17 |
| Date Mfgr Received | 2014-05-17 |
| Date Added to Maude | 2014-07-31 |
| 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 AVENUE |
| 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 | 2014-06-13 |
| Model Number | 102515 |
| Catalog Number | 102515 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 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 | 2014-06-13 |