FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 1991428
·
Received February 15, 2011
Report
- Report Number
- 2182208-2011-00149
- Event Type
- Injury
- Date Received
- February 15, 2011
- 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
- MO, US
- Reporter Occupation
- PHYSICIAN
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 LEFT VENTRICULAR LEAD COIL WAS NOT GOOD WITH HIGH IMPEDANCE, HIGH THRESHOLD AND AN APPARENT LEAD FRACTURE. UNDER FLUOROSCOPY ONE ELECTRODE LOOKED TO BE BROKEN AND DETACHED FROM THE LEAD. REPROGRAMMING AROUND THE FRACTURED ELECTRODE WAS NOTED. THE LEAD REMAINS IN USE. 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, INC. | 4968 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R | 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD |