BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1072914 · Received July 10, 2008

    Report

    Report Number
    2183613-2008-00011
    Event Type
    Injury
    Date Received
    July 10, 2008
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE DEVICE WAS VISUALLY INSPECTED, AND THE ELECTRICAL, FUNCTIONAL, AND MECHANICAL PARTS OF THE DEVICE WERE TESTED. NO ELECTRICAL OR FUNCTIONAL ANOMALIES WERE OBSERVED. THE UPPER AND LOWER CASES AND SIDE BAIL COVERS WERE FOUND TO BE CRACKED. THE LEAD FLEX COVER AND BATTERY DRAWER WAS CONTAMINATED. THE BATTERY CONTACTS WERE FOUND TO BE COMPRESSED. DAMAGE TO THE BATTERY CONTACT COULD RELATE TO THE REPORTED EVENT; HOWEVER, THE REPORTED BEHAVIOR COULD NOT BE REPRODUCED. OTHER: IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) STOPPED WORKING WHILE CONNECTED TO A PATIENT IN THE CARDIO THORACIC OPERATING ROOM. THE PATIENT WENT ASYSTOLIC AND WAS RESUSCITATED. THE EPG WAS REPLACED WITHOUT ISSUE. THERE WAS NO LOSS OF POWER, AND THE PACING LED WAS FLASHING AFTER THE DEVICE "STOPPED WORKING". THE BATTERY WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: DEVICE WAS OUT OF SPECIFICATION BUT THIS DOES NOT RELATE TO EVENT, PACE, FAILURE TO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) STOPPED WORKING WHILE CONNECTED TO A PATIENT IN THE CARDIO THORACIC OPERATING ROOM. THE PATIENT WENT ASYSTOLIC AND WAS RESUSCITATED. THE EPG WAS REPLACED WITHOUT ISSUE. THERE WAS NO LOSS OF POWER, AND THE PACING LED WAS FLASHING AFTER THE DEVICE "STOPPED WORKING". THE BATTERY WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention