FDA Adverse Event
Injury
Summary report: N
TRANSVENE
MDR report key: 1854952
·
Received October 5, 2010
Report
- Report Number
- 2182208-2010-00653
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- August 26, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S1
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 DURING AN UPGRADE OF A PATIENT'S IMPLANTED DEFIBRILLATOR, INSULATION CAME OFF THE LEAD PIN. THE LEAD WAS CUT, CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSVENE | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6936 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | 4068 IMPLANTABLE PACING LEAD| D154 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |