VIRTUOSO DR
Report
- Report Number
- 6000144-2010-06172
- Event Type
- Injury
- Date Received
- December 14, 2010
- 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
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THERE WAS FAR FIELD R-WAVE OVERSENSING AND INAPPROPRIATE MODE SWITCHES. ATTEMPTS TO REPROGRAM THE DEVICE RESULTED IN SOME ATRIAL UNDERSENSING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THERE WAS FAR FIELD R-WAVE OVERSENSING AND INAPPROPRIATE MODE SWITCHES. ATTEMPTS TO REPROGRAM THE DEVICE RESULTED IN SOME ATRIAL UNDERSENSING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED AGAIN THAT THERE WAS FAR FIELD R-WAVE OVERSENSING CAUSING INAPPROPRIATE MODE SWITCH. ATTEMPTS TO DECREASE SENSITIVITY RESULTED IN ATRIAL UNDERSENSING. THE DEVICE REMAINS 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 DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154AWG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD |