FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE PACING LEAD
MDR report key: 2790888
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03264
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- 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 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT THE PATIENT RECEIVED SHOCKS FOR ATRIAL FIBRILLATION. THE PATIENT NOTED THAT THE PATIENT NO LONGER FEELS SAFE WITH THEIR DEVICE SYSTEM. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | LEAD/MEDT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |