BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II DR

    MDR report key: 1854745 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04420
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THERE WAS IMPROPER PACING ON HIS DEVICE. THE PATIENT REPORTED THAT HIS HEART RATE WAS LOWER THAN WHERE THE DEVICE WAS PROGRAMMED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD