BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2123840 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-00716
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    February 18, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND ALL INSULATORS WERE BREACHED CUT. IT WAS ALSO NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS CUT, SEVERAL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE EXPOSED DEFIBRILLATOR COIL HAD A WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST NOTED THAT THE LEAD WAS RECEIVED IN MANY PIECES AND DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE GENERATOR CHANGEOUT, IT WAS NOTED THAT THERE WAS AN INSULATION FAILURE ON THE RIGHT VENTRICULAR LEAD. AN ATTEMPT TO REPAIR THE LEAD WAS PERFORMED, AND IT WAS FOUND THAT THERE WAS A BLOOD INGRESS IN THE INNER INSULATION. THE LEAD HAS BEEN 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 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R D224VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7231CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB