BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIX

    MDR report key: 1854819 · Received October 5, 2010

    Report

    Report Number
    2647346-2010-00543
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    K884215
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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 DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI), BUT LATER THE BATTERY LEVEL WAS ACCEPTABLE. IT WAS ALSO REPORTED THAT THE DEVICE WAS NOT CAPTURING CONSISTENTLY. THE CALLER WAS UNSURE IF THE ERI WAS CLEARED. A MAGNET TEST CONFIRMED THE DEVICE TO BE AT ERI. 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 MINIX IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 8340 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 4004 IMPLANTABLE PACING LEAD