BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2123874 · Received June 14, 2011

    Report

    Report Number
    2183613-2011-00137
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 3, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 FOUND THE BATTERY CONTACTS WERE COMPRESSED. THE PRINTED CIRCUIT BOARD WAS ALSO REPLACED DUE TO THE FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING USE, WHILE THE PATIENT NEEDED PACING THERAPY. THE SURGERY CENTER HAD TO EXTERNALLY PACE THE PATIENT UNTIL THEY COULD GET ANOTHER DEVICE HOOKED UP. NO FURTHER 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 Life Threatening| R