FDA Adverse Event
Death
Summary report: N
HEARTMATE II LVAD
MDR report key: 1714603
·
Received June 8, 2010
Report
- Report Number
- 2916596-2010-00133
- Event Type
- Death
- Date Received
- June 8, 2010
- Date of Event
- May 12, 2010
- Report Date
- May 12, 2010
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE HEARTFAILURE NURSE REPORTED THAT, ONE WEEK POST-IMPLANT OF THE LVAD, THE PATIENT HAD REMAINED CRITICALLY ILL IN THE ICU AND WAS EXPERIENCING POST-OP BLEEDING. WAVEFORMS AND LOG FILES WERE SUBMITTED TO THE MANUFACTURER FOR ANALYSIS. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED WHICH SHOWED LEFT VENTRICLE THROMBUS. SUPPORT WAS WITHDRAWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LVAD | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORPORATION | 103695 | 91447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Death |