BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II DR

    MDR report key: 1924182 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06104
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 18, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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 THAT THE PATIENT'S DEVICE WAS BEEPING AND THE PHYSICIAN INQUIRED AS TO WHETHER MEDTRONIC HAD ANY RECORD OF WHAT ALARM WAS CAUSING THE BEEPING. THEY INDICATED THAT THE PATIENT IS NOT ON THE CARELINK SYSTEM. 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 II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD