FDA Adverse Event
Malfunction
Summary report: N
VIRTUOSO II DR
MDR report key: 1925261
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06255
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S157
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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 ATRIAL FIBRILLATION BURDEN AND HIGH RATE PATIENT ALERT TRIPPED. THE COMPLAINANT ALSO INQUIRED WHAT THE ALERT MEANT, AND WHAT TO DO ABOUT IT. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUOSO II DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D274DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |