BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2205732 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04768
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 10, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. WRITE TO LOCKED RAM POR WITH ECC-LIA CONFLICT, ADDRESS=67F6, DATA=09 ON (B)(4)-2011 11:35:57 AND SINGLE BIT ECC ERROR, ADDR=5D2B, DATA=26, ON (B)(4)-2011 00:02:00. A 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(4)-2011 11:35:57.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING THROUGH RADIATION THERAPY AND THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET. 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 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other 4076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD