FDA Adverse Event
Malfunction
Summary report: N
HEARTMATE II SYSTEM CONTROLLER
MDR report key: 2102926
·
Received May 4, 2011
Report
- Report Number
- 2916596-2011-00169
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- 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 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED THE PUMP STOPPING WHEN BENDING OVER. THE LOG FILE HISTORY SHOWED RPM DROPS TO ZERO. THE SYSTEM CONTROLLER WAS SWAPPED OUT WITH ANOTHER SYSTEM CONTROLLER AND NO FURTHER EVENTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II SYSTEM CONTROLLER | LVAD SYSTEM CONTROLLER | DSQ | THORATEC CORP | 103696 | 88542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |