FDA Adverse Event
Injury
Summary report: N
TRANSVENE
MDR report key: 1926109
·
Received December 14, 2010
Report
- Report Number
- 2182208-2010-01012
- Event Type
- Injury
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S1
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, 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 RIGHT VENTRICULAR (RV) LEAD HAD A HISTORY OF OVERSENSING. DURING A ROUTINE DEVICE CHANGE THE HIGH VOLTAGE PORTION OF THE RV LEAD HAD INSULATION OVER THE PIN. THE PHYSICIAN WAS ABLE TO PULL BACK THE INSULATION, HOWEVER THE LEAD THEN TESTED WITH HIGH IMPEDANCES. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF 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 | 66 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |