BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 1902613 · Received November 18, 2010

    Report

    Report Number
    2183613-2010-00307
    Event Type
    Death
    Date Received
    November 18, 2010
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS (13/14) EVENTS THAT OCCURRED AT THIS USER FACILITY. 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

    THIS IS (B)(4) EVENTS THAT OCCURRED AT THIS USER FACILITY IDENTIFIED. 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 OBSERVED. THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER AND UPPER AND LOWER CASES WERE BROKE, THE RING COVER WAS CONTAMINATED, AND THE LEAD FLEX COVER WAS CORRODED.

    Description of Event or Problem · 1

    A CALL TO TECHNICAL SERVICES FROM THE BIOMEDICAL DEPARTMENT REPRESENTATIVE REPORTED, THE PHYSICIAN BELIEVES THE EXTERNAL PULSE GENERATORS (EPG) MAY BE INDUCING VENTRICULAR FIBRILLATION, AND TWO DEATHS HAVE BEEN NOTED. THE SERIAL NUMBER OF THE EPG CONNECTED TO PATIENTS AT THE TIME OF THESE UNTOWARD EVENTS IS UNKNOWN. THE CALLER FURTHER REPORTED, DEPARTMENT QUARTERLY CHECKS WERE COMPLETED AND FOUND NO ISSUES WITH THE EXTERNAL GENERATORS.

    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 Death| H| L| R