FDA Adverse Event
Injury
Summary report: N
CAPSURE Z
MDR report key: 3153332
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05949
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- December 10, 2010
- Report Date
- May 21, 2024
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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 THE RA (RIGHT ATRIAL) LEAD HAD DISLODGED. THE LEAD WAS ELECTRICALLY ABANDONED. THE PATIENT IS ENROLLED IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255991 | CAPSURE Z | PERMANENT PACEMAKER ELECTRODE | DTB | MPRI | 5034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention| H | 5023M LEAD |