BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENE

    MDR report key: 1992664 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00205
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WAS REPORTED THAT THERE WERE NON-SUSTAINED TACHYCARDIA EPISODES PRESENT, SOME WITH 150 MSEC INTERVALS, AND THAT THERE WAS INCREASED CURRENT DRAIN NOTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE NON-SUSTAINED TACHYCARDIA EPISODES PRESENT, SOME WITH 150 MSEC INTERVALS, AND THAT THERE WAS INCREASED CURRENT DRAIN NOTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION REPORTED THAT THE LEAD INTEGRITY ALERT TRIGGERED. THE PATIENT PERFORMED A CARELINK TRANSMISSION AND IT WAS NOTED THAT NOISE AND OVERSENSING APPEARED ON THE RIGHT VENTRICULAR PACE SENSE PORTION OF THE LEAD.

    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 64 YR Other 5227D IMPLANTABLE ADAPTOR| 6933 IMPLANTABLE TACHY LEAD| D224VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6933 IMPLANTABLE TACHY LEAD| 7227 IMPLANTABLE PACEMAKER/CARDIO/DEFIB