BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1802810 · Received August 17, 2010

    Report

    Report Number
    2183613-2010-00144
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    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
    FL, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 REPORTED EVENT. HEART LEAD FLEX IS OUT OF SPECIFICATION. BATTERY CONTACTS ARE COMPRESSED, BATTERY DRAWER IS CONTAMINATED, SIDE BAIL COVERS ARE BROKEN, AND UPPER AND LOWER CASES ARE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO VOLTAGE FROM VENTRICULAR OUTPUT. FOLLOW-UP INFORMATION RECEIVED FOUND THE DEVICE WAS CONNECTED TO A PATIENT AT THE TIME OF THE EVENT. THE DEVICE WAS SWITCHED TO A DIFFERENT ONE RIGHT AWAY, AND THERE WERE NO PATIENT COMPLICATIONS.

    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