FDA Adverse Event
Malfunction
Summary report: N
VIRTUOSO DR
MDR report key: 2611078
·
Received June 11, 2012
Report
- Report Number
- 6000144-2012-03569
- Event Type
- Malfunction
- Date Received
- June 11, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 DEVICE WAS SHOWING INCREASED SENSING INTEGRITY COUNTS. IT WAS SUSPECTED THAT THE PATIENT'S OXYGEN MACHINE MAY HAVE BEEN CAUSING THE INCREASE IN COUNTS. IT WAS NOTED THAT THERE WERE "NO ILL EFFECTS TO PATIENT NOR WERE THERE ANY INAPPROPRIATE TREATMENTS". THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other | 5554 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |