BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1434103 · Received August 10, 2009

    Report

    Report Number
    2182208-2009-00264
    Event Type
    Injury
    Date Received
    August 10, 2009
    Date of Event
    June 10, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE. ANALYSIS OF THAT DATA REVEALED LOW RESISTANCE/IMPEDANCE; THE HV-COIL AND RING-COIL IMPEDANCE VALUES ARE LESS THAN 15 OHMS THROUGHOUT THE RECORDING PERIOD. ANALYSIS OF THE DATA ALSO REVEALED NOISE, AND THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 202068. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    REVIEW OF DEVICE DATA SHOWED LOW IMPEDANCE, < 15 OHMS, SIGNIFYING INSULATION DEGRADATION. OVERSENSING WAS ALSO NOTED. 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 55 YR Required Intervention 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6933 IMPLANTABLE TACHY LEAD