BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2131547 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00295
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 26, 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
    MO, 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 INITIAL REPORT. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE, LEAD FLEX COVER, HEART WIRE CONTACTS, BATTERY CONTACTS, AND BATTERY FLEX WERE CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY DRAWER WAS OUT OF SPECIFICATION, THE KEYBOARD PAD WAS COSMETICALLY SCRATCHED, THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION (SEGMENTS MISSING) AND THE BATTERY DRAWER O-RING WAS MISSING.

    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 THE EPG (EXTERNAL PULSE GENERATOR) QUIT PACING WHILE ON A PACEMAKER DEPENDENT PATIENT. ANOTHER UNIT WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 66 YR Life Threatening| R