BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENE

    MDR report key: 1861683 · Received October 8, 2010

    Report

    Report Number
    2182208-2010-00717
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DATA REVEALED "VARYING RESISTANCE/IMPEDANCE". A TREND OF VARYING IMPEDANCE ON THE RIGHT VENTRICULAR PACE LEAD BETWEEN 592 OHM ON (B)(6) 2009 AND IMPEDANCE AS HIGH AS 848 OHMS (B)(6) 2010 IS OBSERVED. UNTIL THE WEEK OF (B)(6) 2009, THE TREND IS STABLE AT APPROXIMATELY 600 OHMS. ALSO "INTERFERENCE/NOISE" WAS OBSERVED. BETWEEN THE DATES OF (B)(6) 2009 AND (B)(6) 2010 AND AN AVERAGE OF 57.1 V-SIC COUNTS/DAY IS OBSERVED. BETWEEN THE DATES OF (B)(6) 2010 AND (B)(6) 2010, THE AVERAGE VALUE IS 28.1 COUNTS/DAY. ELEVATED SIC CAN INDICATE THE PRESENCE OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS OVERSENSING. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 6939 IMPLANTABLE TACHY LEAD| 6933 IMPLANTABLE TACHY LEAD| D154VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB