FDA Adverse Event
Injury
Summary report: N
CAPSUREEPI
MDR report key: 4943201
·
Received July 27, 2015
Report
- Report Number
- 2182208-2015-02243
- Event Type
- Injury
- Date Received
- July 27, 2015
- Date of Event
- December 9, 2013
- Report Date
- July 16, 2015
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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 THE LEAD EXHIBITED NOISE. THE LEAD WAS DEACTIVATED. THE PATIENT IS A PARTICIPANT IN THE PAN-PSR CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 486854 | CAPSUREEPI | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC, INC. | 4968-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00009 YR | Required Intervention | ST JUDE IPG |