MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-02-06 for HEARTMATE II LVAS manufactured by Thoratec Corporation.
[5349622]
Found down and unresponsive with lvad alarming due to low battery.
Patient Sequence No: 1, Text Type: D, B5
[12805053]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 4492444 |
| MDR Report Key | 4492444 |
| Report Source | * |
| Date Received | 2015-02-06 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-05-05 |
| Date Facility Aware | 2015-01-05 |
| Report Date | 2015-02-06 |
| Date Reported to FDA | 2015-02-06 |
| Date Reported to Mfgr | 2015-02-06 |
| Date Added to Maude | 2015-02-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE II LVAS |
| Generic Name | LVAD |
| Product Code | OKR |
| Date Received | 2015-02-06 |
| Device Age | 867 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-06 |