FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 2811565
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03739
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 RIGHT VENTRICULAR LEAD HAD UNDEFINED RESISTANCE AND WAS FRACTURED. THE LEAD WAS PROGRAMMED OFF. 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. | 4965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention | (B)(4) IMPLANTABLE PULSE GENERATOR| 4965 IMPLANTABLE PACING LEAD |