FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 2213478
·
Received August 16, 2011
Report
- Report Number
- 2182208-2011-02007
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- January 1, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- P950024/S2
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD HAD A FRACTURE ON THE SENSING PORTION OF THE LEAD. THE LEAD WAS REPROGRAMMED AND REMAINED IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE EPI | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | 4968 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |