FDA Adverse Event
Injury
Summary report: N
CAPSURE SENSE
MDR report key: 4161801
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11414
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 27, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 THAT THERE WAS ATRIAL LEAD PACING THRESHOLD PROBLEM. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT OCCURRENCE OF PACEMAKER ATRIAL CONNECTOR STUCK AND UNABLE TO CONNECT LEAD AGAIN. THE PACEMAKER 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 |
|---|---|---|---|---|---|---|---|
| 640231 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | A3DR01 IPG |