FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
MDR report key: 2800920
·
Received October 18, 2012
Report
- Report Number
- 2916596-2012-00994
- Event Type
- Injury
- Date Received
- October 18, 2012
- Date of Event
- September 28, 2012
- Report Date
- September 28, 2012
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. 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 LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT PRESENTED TODAY FOR A SCHEDULED PROCEDURE AND ADMITTED THAT HIS PUMP HAD BEEN "STOPPING" AGAIN. REVIEW OF THE LOG FILE SHOWED NUMEROUS PUMP STOPPAGES OVERNIGHT. THE PT WAS ADMITTED TO THE HOSP. THE PT RECEIVED A PUMP EXCHANGE ON (B)(6) 2012.
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 | 90919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |