FDA Adverse Event
Injury
Summary report: N
VIRTUOSO VR
MDR report key: 2790961
·
Received October 15, 2012
Report
- Report Number
- 6000144-2012-05621
- Event Type
- Injury
- Date Received
- October 15, 2012
- Date of Event
- August 24, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, 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 WAS SEEN IN THE EMERGENCY ROOM AFTER THE WAVELET ALGORITHM DID NOT STOP AN INAPPROPRIATE THERAPY. THE PATIENT WAS FOUND TO HAVE BEEN IN ATRIAL FIBRILLATION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUOSO VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154VWC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Life Threatening | 6947 IMPLANTABLE TACHY LEAD |