FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 3152237
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06893
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Report Date
- April 24, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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: 4076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LEAD MONITOR WARNING FOR LOW IMPEDANCE WITH THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT IS BEING MONITORED. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED DUE TO LOW IMPEDANCE AND HIGH THRESHOLDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252868 | 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| L| R | (B)(4) IMPLANTABLE PACEMAKER |