BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENE SVC/CS

    MDR report key: 1860924 · Received October 7, 2010

    Report

    Report Number
    2182208-2010-00762
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 21, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 IS REPORTED THAT SVC IMPEDANCE INCREASED IN LAST TWO WEEKS AND THEN BACK DOWN TO HISTORIC RANGE. PATIENT HEARD ALERT (LEAD INTEGRITY ALERT IS LOADED) AND WENT TO MEDICAL CENTER. WHEN TESTING WITH PATIENT MOVING AROUND THE IMPEDANCES JUMPED TO OVER 100OHMS. THE LEAD REMAINS IN USE. 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 SVC/CS IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6933 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other 6932 IMPLANTABLE TACHY LEAD| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB