BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE SVC/CS

    MDR report key: 2121695 · Received June 13, 2011

    Report

    Report Number
    2182208-2011-00705
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S5
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DISTAL PORTION OF THE 6936 LEAD WAS RETURNED, ANALYZED AND DEFIBRILLATOR CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION HAD COSMETIC METAL ION OXYDATION (MIO), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE DISTAL PORTION OF THE 6937 LEAD WAS RETURNED, ANALYZED AND DEFIBRILLATOR CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DEFIBRILLATION CONDUCTOR (NOT OBSTRUCTED), THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IS OVERSENSING. IT WAS FURTHER REPORTED THAT OVERSENSING TRIGGERED THE LEAD INTEGRITY ALERT. IT WAS FURTHER REPORTED THAT THE HELIX WOULD NOT RETRACT AND THAT THE OUTER INSULATION WAS BREACHED. THE LEAD WAS REMOVED AND REPLACED. AN ADDITIONAL RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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. 6937 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB