MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-17 for HEARTMATE II manufactured by Thoratec.
[61118949]
Pump thrombosis. Pt was doing well; complained of dizziness; diuretics stopped. Seen in office. Echo revealed left ventricle dilated. Started inotrope support, high dose heparin. Pump exchange on (b)(6) 2016. Discharged to home on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6132019 |
| MDR Report Key | 6132019 |
| Date Received | 2016-11-17 |
| Date of Report | 2016-11-07 |
| Date of Event | 2016-10-13 |
| Date Added to Maude | 2016-11-29 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEARTMATE II |
| Generic Name | LEFT VENTRICULAR ASSIST DEVICE (LVAD) |
| Product Code | OKR |
| Date Received | 2016-11-17 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC |
| Manufacturer Address | BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-11-17 |