BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1992570 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00025
    Event Type
    Malfunction
    Date Received
    February 15, 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
    ME, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SENT TO THE BIOMEDICAL ENGINEER STATING THE BATTERY SYMBOL CAME ON, AND THE DEVICE SHUT OFF. PATIENT INVOLVEMENT WAS UNKNOWN; HOWEVER, THE BIOMEDICAL ENGINEER STATED THE HOSPITAL DID NOT FILL OUT AN INCIDENT REPORT. THE BIOMEDICAL ENGINEER TESTED THE DEVICE AND FOUND NO ISSUES.

    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