FDA Adverse Event
Death
Summary report: N
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
MDR report key: 2484796
·
Received March 7, 2012
Report
- Report Number
- 2916596-2012-00186
- Event Type
- Death
- Date Received
- March 7, 2012
- Date of Event
- February 6, 2012
- Report Date
- February 6, 2012
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 MANUFACTURER'S INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS BACTEREMIC RESULTING IN AN ADMISSION THE WEEK PRIOR. NO SOURCE WAS IDENTIFIED AND HE WAS BEING TREATED. THE PATIENT THEN EXPIRED DUE TO A BRAIN HEMORRHAGE. THE HOSPITAL WAS INTERESTED IF THE VAD WAS SEEDED WITH THE INFECTION AND POSSIBLY THE SOURCE OF THE BACTERMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE | DSQ: LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORP. | 103695 | 100755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Death |