FDA Adverse Event
Death
Summary report: N
VIRTUOSO DR
MDR report key: 2171961
·
Received July 22, 2011
Report
- Report Number
- 2647346-2011-00949
- Event Type
- Death
- Date Received
- July 22, 2011
- Date of Event
- June 20, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED SLOW VENTRICULAR TACHYCARDIA WHICH WAS IN AND OUT OF THE DETECTION ZONE. THE DEVICE DID NOT DETECT THE ARRHYTHMIA AND THERAPY WAS DELAYED. THE PATIENT EXPIRED DUE TO CARDIAC ARREST. FURTHER DETAILS SURROUNDING THE DEATH HAVE BEEN REQUESTED AND NOT RECIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUOSO DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154AWG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death| O |