FDA Adverse Event
Malfunction
Summary report: N
VIRTUOSO II DR
MDR report key: 1803313
·
Received August 17, 2010
Report
- Report Number
- 2647346-2010-00473
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S157
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 RECEIVED INAPPROPRIATE SHOCKS. IT WAS ALSO REPORTED THERE WAS HIGH RATE SENSING IN ATRIAL AND VENTRICULAR CHANNELS IN SOME EPISODES. THERE WERE FREQUENT NOISE EPISODES. EMI (ELECTROMAGNETIC INTERFERENCE) WAS SUSPECTED. DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 | 76 YR | Other | 6949 IMPLANTABLE TACHY LEAD |