BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 253732 · Received May 10, 1999

    Report

    Report Number
    2182208-1999-00113
    Event Type
    Injury
    Date Received
    May 10, 1999
    Date of Event
    February 10, 1999
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SCV LEAD FRACTURE. SCV LEAD FRACTURE. PATCH LEAD FOLDED OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE Implant IMPLANTABLE TACHY LEAD LWS MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION 6963 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6999 IMPLANTABLE TACHY LEAD| 6966 IMPLANTABLE TACHY LEAD| 7221B IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6943 IMPLANTABLE TACHY LEAD