FDA Adverse Event
Injury
Summary report: N
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
MDR report key: 3153318
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05942
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 28, 2013
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD A DECREASE IN R WAVE TO A LOW MEASUREMENT. THE RV LEAD WAS REPOSITIONED AND 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 |
|---|---|---|---|---|---|---|---|
| 256139 | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | D314DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |