FDA Adverse Event
Injury
Summary report: N
HEARTMATE XVE LVAS
MDR report key: 1241051
·
Received November 20, 2008
Report
- Report Number
- 2916596-2008-00162
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 4, 2008
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD AND THE PT REMAINS ONGOING. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE DEVICE WAS MAKING NOISES. INFO WAS PROVIDED TO THE MFR THROUGH VENT FILTER AND WAVEFORM ANALYSIS. A DECISION WAS MADE BY THE SURGEON TO EXCHANGE THE PT'S LVAD WITH ANOTHER LVAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE XVE LVAS | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORP. | 1270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |