BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 3992123 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14887
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S DAUGHTER REPORTED THAT THE PATIENT WAS IN HOSPICE CARE AND WAS HAVING SOME TWITCHING AND SPASMS. THE HOSPICE NURSE VIA THE PHONE THOUGHT THE PATIENT MAY BE RECEIVING SHOCKS FORM THE DEVICE. FOLLOW UP WAS CONDUCTED THAT INDICATED THAT THE PHYSICIAN PUT IN AN ORDER TO TURN THE DEVICE OFF. THE DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470438 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Life Threatening| R 6943-58V LEAD