BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131689 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00316
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 18, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 CONFIRMED THE INITIAL REPORT, THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER CASE, LOWER CASE, BOTH BAIL COVERS AND RING COVER WERE BROKEN, THE LEAD FLEX COVER WAS CONTAMINATED, THE HEART WIRE CONTACTS WERE PATINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE LCD SCREW WAS MISSING AND THE ENCODER FLEX WAS DAMAGED.

    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 LOWER DISPLAY WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOWER DISPLAY WAS NOT FUNCTIONING. THE EXTERNAL PULSE GENERATOR (EPG) WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    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 Other