BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1802828 · Received August 17, 2010

    Report

    Report Number
    2183613-2010-00136
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    May 5, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ELECTRICAL ANOMALIES WERE FOUND. THE UPPER AND LOWER CASES, BATTERY RELEASE O-RING, RELEASE SPRING, BATTERY DRAWER, AND BATTERY FLEX WERE ALL WET/CONTAMINATED. THE BATTERY CONTACTS WERE WET, CONTAMINATED, AND DISCOLORED, AND ONE SIDE BAIL COVER WAS BROKE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHUT OFF THREE TIMES ON ITS OWN. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO PATIENT HARM. THE BIOMEDICAL ENGINEER COULD NOT REPRODUCE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 5388 INSTRUMENT (EPG ANALYZER) SHUT OFF THREE TIMES. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM TO ANY PATIENTS. THE BIOMED ENGINEER COULD NOT DUPLICATE THE ERROR. IT WAS REQUESTED THAT THE INSTRUMENT BE RETURNED FOR SERVICE AND REPAIR.

    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| R