FDA Adverse Event
Malfunction
Summary report: N
VIRTUOSO II DR
MDR report key: 2791307
·
Received October 15, 2012
Report
- Report Number
- 6000144-2012-05341
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- May 12, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S157
- Removal / Correction Number
- Z-0117-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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
IT WAS REPORTED THAT THE DEVICE DETECTED A SUPRAVENTRICULAR TACHYCARDIA (SVT) EPISODE AS VENTRICULAR TACHYCARDIA (VT) DUE TO RAPID ONSET OF SVT. THE SVT WAS TREATED WITH ANTI-TACHYCARDIA PACING (ATP). 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 II DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D274DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other | 5076 X2 IMPLANTABLE PACING LEADS| 6947 IMPLANTABLE TACHY LEAD |