BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2132061 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00254
    Event Type
    Malfunction
    Date Received
    June 16, 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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS FOUND THE BATTERY DRAWER, RING COVER, AND TWO SIDE BAIL COVERS WERE BROKEN. THE UPPER AND LOWER CASES, BATTERY RELEASE, AND LEAD FLEX COVER WERE CONTAMINATED, AND THE RING WAS FOUND TO BE BENT.

    Description of Event or Problem · 1

    THE EPG (EXTERNAL PULSE GENERATOR) WAS RETURNED TO THE MANUFACTURER FOR REPAIR. IT WAS NOTED THE CONDITION WAS FOUND DURING BIOMEDICAL ENGINEER TESTING. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    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