FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 1992684
·
Received February 15, 2011
Report
- Report Number
- 6000094-2011-00333
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- November 22, 2010
- Report Date
- March 28, 2024
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Removal / Correction Number
- ASKU
- 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. 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 SIC (SHORT INTERVAL COUNT) WAS HIGH. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN 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 S.A. | 4968 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |