BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA AF MRI S

    MDR report key: 7620932 · Received June 20, 2018

    Report

    Report Number
    9614453-2018-02306
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    June 15, 2018
    Report Date
    October 2, 2018
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. M IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) GAVE ABNORMAL IMPEDANCE MEASUREMENTS. THE PHYSICIAN DECIDED NOT TO USE THIS ICD AND IMPLANTED A DIFFERENT ICD INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463112 EVERA AF MRI S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC EUROPE SARL DVMC3D1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR