BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2003395 · Received March 1, 2011

    Report

    Report Number
    2183613-2011-00063
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. THE UPPER AND LOWER CASES WERE FOUND TO BE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WILL NOT PACE FOR 15 SECONDS AFTER THE BATTERY IS REMOVED. THE DEVICE LOSES POWER TOO QUICKLY. FOLLOW-UP INFORMATION WAS SUBSEQUENTLY RECEIVED REPORTING THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE CONDITION WAS FOUND DURING BIOMEDICAL ENGINEER TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WILL NOT PACE FOR 15 SECONDS AFTER THE BATTERY IS REMOVED. THE DEVICE LOSES POWER TOO QUICKLY. FOLLOW-UP ATTEMPTS TO DETERMINE IF THERE WAS PATIENT INVOLVEMENT WERE UNSUCCESSFUL.

    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