BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3860446 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05431
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 10, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS: 4193-78 LEAD IMPLANTED: (B)(6) 2006; 5076-52 LEAD IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT'S LEAD WAS "BROKEN". THE SPOUSE FURTHER REPORTED THAT THE LEAD REMAINED IMPLANTED UNTIL THE PATIENT PASSED AWAY AS THE PATIENT WAS TOO ILL FOR THE REPLACEMENT PROCEDURE. THE PATIENT DIED IN A MANNER UNRELATED TO THE LEAD OR DEVICE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341807 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR C154DWK ICD