BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1992532 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00022
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOMEDICAL ENGINEER RECEIVED SEVERAL REPORTS OF MODEL 5388 EPGS (EXTERNAL PULSE GENERATORS) SHUTTING DOWN. THE DEVICE SERIAL NUMBERS WERE NOT RECORDED IN ALL CASES. INVESTIGATION OF THE ISSUE BY THE BIOMEDICAL ENGINEER FOUND SOME OF THE BATTERIES TO BE LOW, AND BATTERY CLIPS HAD LOST THEIR TENSION AND WERE COMPRESSED AFTER A LOT OF USE. IN ALL CASES, STAFF INTERVENTION AVOIDED ANY PROBLEMS, AND THE PATIENT STATUS WAS REPORTED TO BE FINE, WITH NO ILL EFFECTS.

    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