BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO VR

    MDR report key: 2790275 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05590
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. EVALUATION SUMMARY FOR: (B)(4) PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND REVEALED THAT NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE VIEWED THE REMOTE MONITORING TRANSMISSION AND FOUND THAT THE LEAD IMPEDANCE TRENDS WERE ALL BLANK. THE INFORMATION WAS ABLE TO BE RECOVERED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 6949 IMPLANTABLE TACHY LEAD