FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 3051036
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05904
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- January 8, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6944, IMPLANTABLE DEFIB LEAD, (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT WITHHOLD THERAPY WHEN THE PATIENT WAS EXPERIENCING ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149514 | VIRTUOSO DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Life Threatening | 5076 IMPLANTABLE PACING LEAD |