FDA Adverse Event
Malfunction
Summary report: N
VIRTUOSO DR
MDR report key: 2812120
·
Received October 31, 2012
Report
- Report Number
- 2647346-2012-01756
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT COMPLAINED OF THE AREA AROUND THE DEVICE BEING "WARM ON THE INSIDE". THE SPOUSE SAID "IT DID FEEL WARM". THE PATIENT WAS TAKEN TO THE ER BUT WAS RELEASED AFTER BLOOD TESTS WERE "OK". IT WAS NOTED THAT THE PATIENT HAS DEMENTIA AND HAS NOT "COMPLAINED [FOR FOUR DAYS]". 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 | 75 YR | Other | 1388TC COMPETITOR IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |