FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 2953045
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01889
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 25, 2012
- Report Date
- November 25, 2012
- 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
- CT, US
- 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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY REMOTE TRANSMISSION THE PATIENT WAS ADMITTED FOR MULTIPLE INAPPROPRIATE SHOCKS. THE DISCRIMINATOR ON THE IMPLANTED DEFIBRILLATOR SHOCKED FOR ATRIAL ARRHYTHMIAS WITH RAPID VENTRICULAR RESPONSE. 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 |
|---|---|---|---|---|---|---|---|
| 57743 | VIRTUOSO DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| L | 6947 IMPLANTABLE TACHY LEAD |