FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 3153089
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05812
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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: 6947 IMPLANTABLE TACHY LEAD, (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH THRESHOLDS AND SMALL P-WAVES. THE LEAD WAS FOUND TO BE PULLED BACK AND HAD LOST THE CURVE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256006 | CAPSUREFIX | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 4068-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR | Hospitalization| R | D314DRG IMPLANTABLE DEFIBRILLATOR |