BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 3993232 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14666
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LWS
    PMA / PMN Number
    P980016
    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
    469092 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Life Threatening LFJ250412V DEFIB LEAD