FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 4162639
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12692
- Event Type
- Injury
- Date Received
- October 10, 2014
- Report Date
- August 14, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
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 MEDICAL PRODUCTS: PRODUCT ID: 4068-58 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD WAS UNDERSENSING AND OVERSENSING NOISE CAUSING THE DEVICE BATTERY TO REACH ELECTIVE REPLACEMENT INDICATOR (ERI). THE ATRIAL LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 644521 | CAPSUREFIX | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 4068-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| R | ADDR01 IPG |