FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3993311
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09373
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 30, 2014
- Report Date
- June 30, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
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 THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND OVERSENSING DUE TO A POSSIBLE FRACTURE. THE RA LEAD WAS REPROGRAMMED, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND IS AWAITING A FULL SYSTEM EXTRACTION AND NEW SYSTEM REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471377 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5592-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Hospitalization| R | 694965 LEAD 2007 |