BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1992189 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00052
    Event Type
    Injury
    Date Received
    February 15, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 DUPLICATE THE CUSTOMER COMMENTS. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE, HEART WIRE CONTACTS, BATTERY DRAWER AND HEART LEAD FLEX WERE CONTAMINATED, THE SIDE BAIL COVERS WERE BROKEN, THE LEAD FLEX COVER AND OUTPUT CONNECTORS WERE CORRODED, THE BATTERY CONTACTS WERE COMPRESSED AND CONTAMINATED, AND THE KEYBOARD WAS SCRATCHED.

    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) PACED "R" ON "T," WITH THE LOWEST SENSITIVITY SETTING, WHILE THE DEVICE WAS CONNECTED TO A PATIENT. THERE WERE MULTIPLE PACING SPIKES ON THE T-WAVE. THE DEVICE WAS REPLACED, AND THE PROBLEM WAS REPORTEDLY SOLVED. 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 Life Threatening| R