FDA Adverse Event
Injury
Summary report: N
TRANSVENE
MDR report key: 1072534
·
Received July 10, 2008
Report
- Report Number
- 2182208-2008-00192
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- April 9, 2008
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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. EVALUATION SUMMARY: OUTER INSULATION BREACHED; FULL LEAD RETURNED IN SEGMENTS.
Description of Event or Problem · 1
ASKU
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 | Required Intervention | 7229CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6933 IMPLANTABLE TACHY LEAD |