BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131496 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00964
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS FOUND THAT THE HEART LEAD FLEX WAS OUT OF SPECIFICATION. THE MAIN PRINTED CIRCUIT BOARD WAS ALSO REPLACED, ONE SIDE BAIL COVER WAS BROKEN, AND THE RING WAS BENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER DUE TO A FIELD ADVISORY. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR 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, INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other