FDA Adverse Event
Injury
Summary report: N
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
MDR report key: 2964526
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02122
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- September 26, 2012
- Report Date
- December 27, 2012
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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 PRODUCTS 5076 IMPLANTABLE PACING LEAD (B)(6) 2006; (B)(4) MECHANICAL VALVE (B)(6) 1989.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST WALL STIMULATION AND ELEVATED RIGHT VENTRICULAR (RV) LEAD THRESHOLD. THE CHEST WALL STIMULATION SUBSIDED ON IT'S OWN, BUT THE THRESHOLD REMAINS HIGH. THE RV LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67494 | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |