BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 112623 · Received May 30, 1997

    Report

    Report Number
    112623
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    April 24, 1997
    Report Date
    May 30, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INDICATIONS: TEN YEAR OLD BOY WITH A CONGENITAL LONG QT SYNDROME WITH ASSOCIATED POLYMORPHIC VENTRICULAR TACHYCARDIA AND SYNCOPE. HE HAS BEEN TREATED WITH ICD INSERTION IN THE PAST. ON FOLLOW UP HE HAS BEEN NOTED TO HAVE A FRACTURE OF HIS SUPERIOR VENA CAVAL DEFIBRILLATION LEAD. ELECTIVE REPLACEMENT OF THIS DEVICE IS THUS ADVISED. AT THE TIME OF DEVICE REPLACEMENT THE LEAD WILL BE TESTED AND RE-UTILIZED IF THEY HAVE ACCEPTABLE THRESHOLDS. PROCEDURE: THE LEADS WERE DETACHED FROM THE PULSE GENERATOR. THE PULSE GENERATOR WAS REMOVED FROM THE FIELD. THE IMPEDANCE WAS THEN ASSESSED ON THE SUPERIOR VENA CAVAL LEAD AND FOUND TO BE HIGH CONSISTENT WITH FRACTURE. PACING AND SENSING THRESHOLDS ON THE RIGHT VENTRICULAR DEFIBRILLATION AND PACING LEAD WERE THEN DETERMINED. THEY WERE FOUND TO BE HIGH AND ACCEPTABLE AND THE DECISION WAS MADE TO REUTILIZE THESE LEADS. PACING AND SENSING THRESHOLD DETERMINATION: THE MEDTRONIC MODEL 6933-100 SUPERIOR VENA CAVAL DEFIBRILLATION LEAD WAS TESTED AND FOUND TO HAVE A VERY HIGH THRESHOLD CONSISTENT WITH LEAD FRACTURE. CONCLUSIONS: FRACTURE OF THE SUPERIOR VENA CAVAL DEFIBRILLATION LEAD. THIS LEAD WAS CAPPED AND ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DEFIBRILLATION LEAD LWS MEDTRONIC, INC. 6933-110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other