BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131409 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00269
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 18, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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): ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE CONTAMINATED AND BROKEN, THE BATTERY RELEASE, FOUR CONTROL KNOBS, RING COVER, TWO SIDE BAIL COVERS, HEART BLOCK, LEAD FLEX COVER, TWO PRINTED CIRCUIT BOARD (PCB) SCREWS, BOARD CONNECTOR CABLES, OUTPUT CONNECTORS, BATTERY DRAWER, KEYBOARD PAD, MAIN PCB, ENCODER FLEX AND HEART LEAD FLEX WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, TWO SIDE BAILS WERE MISSING, AND THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) WAS ATTACHED TO A PATIENT, AND IT SUDDENLY STOPPED PACING DURING A CASE. THE EPG WAS CHANGED WITH ANOTHER UNIT, WHICH RESOLVED THE ISSUE. IT APPEARED TO HAVE BEEN CONTAMINATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention