BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 1051502 · Received May 12, 2008

    Report

    Report Number
    1051502
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 12, 2008
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED AFTER MULTIPLE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCKS. PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR PLACED TWO YEARS PRIOR. UPON INTERROGATION OF THIS DEVICE, IT WAS CLEAR TO THE CARDIOLOGIST THAT THE PATIENT HAD A LEAD FRACTURE CAUSING OVER-SENSING OF THE ELECTRICAL INTERFERENCE WITH SUBSEQUENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCKS. IT WAS THEN DECIDED TO IMPLANT A NEW LEAD TO ENSURE PROPER FUNCTION OF THE DEVICE. THE ORIGINAL LEAD WAS CAPPED OFF AND LEFT IN PLACE. A NEW GENERATOR WAS ALSO PLACED AT THIS TIME DUE TO THE ORIGINAL GENERATOR BEING OVERLY USED BY THE FAULTY LEAD. OF NOTE IS THAT THE PATIENT RECEIVED A NOTIFICATION LETTER FROM MEDTRONIC SIX MONTHS BEFORE THIS EVENT REGARDING THE POSSIBILITY OF A LEAD MALFUNCTION WITH HIS PARTICULAR MODEL. IT IS UNCLEAR WHY THE PATIENT FAILED TO FOLLOW-UP WITH HIS PROVIDER REGARDING THIS POSSIBILITY. THE PATIENT HAS SINCE RECOVERED FROM THIS PROCEDURE AND HAS BEEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, ICD LWS MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT 694965 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR