FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 2951972
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00331
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 9, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061/S10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 OVERSENSING ON THE VENTRICULAR LEAD ON TWO DIFFERENT OCCASIONS. IN BOTH OCCURRENCES, THE LEAD SENSITIVITY WAS REPROGRAMMED. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56782 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |