BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3993224 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09433
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A SHOCK (EXTERNAL SHOCK) WHILE STANDING IN A PUDDLE OF WATER WHILE AT THE GAS STATION. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AND THERE WAS HEAT COMING FROM THE DEVICE. TODAY, THERE IS A BLISTER ABOUT THE SIZE OF A QUARTER ON TOP OF THE SKIN BETWEEN THE HEADER AND THE DEVICE. ALL SESSION TODAY REVEALED THERE WERE NO SHOCKS AND ALL PARAMETERS/MEASUREMENTS ARE WITHIN NORMAL RANGE. ACCORDING TO THE TRENDS, THERE WAS A CHANGE TO COIL IMPEDANCES AND SENSING ON THE DAY OF THE INCIDENT. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470162 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Life Threatening 7232CX ICD