FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 3960037
·
Received July 17, 2014
Report
- Report Number
- 2916596-2014-01211
- Event Type
- Injury
- Date Received
- July 17, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 17, 2014
- Manufacturer
- THORATEC CORP.
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE SUBJECT DEVICE WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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. IT WAS REPORTED THAT THE PT UNDERWENT A PUMP EXCHANGE. IT WAS REPORTED THAT THE PT WAS EXCHANGED OVER TO ANOTHER MFR'S DEVICE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417794 | HEARTMATE II LVAS | DSQ: LEFT VENTRICULAR ASSIST DEVICE | DSQ | THORATEC CORP. | 106015 | 139063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Required Intervention |