FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 2130626
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10196
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- December 22, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE CLINIC WITH AN ATRIAL LEAD WARNING. IT WAS RPORTED THAT THE BIPOLAR IMPEDANCE WAS LOWER THAN THE UNIPOLAR IMPEDANCE. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS 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 SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4524 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | E2DR01 IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD |