FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3153381
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05980
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Report Date
- March 18, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE INCREASING VENTRICULAR THRESHOLDS AND DECREASING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD, ESPECIALLY IN THE PAST SIX MONTHS. UNIPOLAR MEASUREMENTS WERE SIMILAR TO BIPOLAR. THE PATIENT IS SENSITIVE TO VENTRICULAR PACING AND REPORTED OCCASIONALLY FEELING A ¿JABBING¿ SENSATION WITH THE INCREASED OUTPUTS. AN X-RAY SHOWED NO ABNORMALITIES AND THE LEAD REMAINS IN USE WITH CONTINUED MONITORING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258900 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |