BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2810948 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06407
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    Z-0112-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INDICATED THAT THE PACEMAKER "IS CONSTANTLY OFF BALANCE" AS IT SHOULD BE AT 71 AND IS "ANYWHERE FROM 70 TO SOME OTHER NUMBER." THE PATIENT HAD NOT BEEN SEEN BY A PHYSICIAN, SO NO ADDITIONAL INFORMATION WAS AVAILABLE. THE DEVICE IS STILL 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 CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other 5071 IMPLANTABLE PACING LEAD| 5076-2 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD