BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1863367 · Received October 9, 2010

    Report

    Report Number
    2183613-2010-00274
    Event Type
    Injury
    Date Received
    October 9, 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
    MA, 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. BATTERY CONTACTS ARE COMPRESSED, RING COVER IS CONTAMINATED, ONE SIDE BAIL COVER IS BROKEN, AND THE KEYBOARD IS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS RESTING AND SUDDENLY YELLED OUT "I FEEL LIGHTHEADED!" AND BECAME UNCONSCIOUS. THE PATIENT WAS NOTED TO BE IN ASYSTOLE ON THE MONITOR. A CODE WAS CALLED IMMEDIATELY. UPON INVESTIGATION OF THE EPG (EXTERNAL PULSE GENERATOR), THE SCREEN WAS NOTED TO BE POWERED OFF. THE PATIENT WAS NOT BEING PACED. THE DEVICE HAD BEEN LOCKED THROUGHOUT THE ENTIRE SHIFT, HAD NOT BEEN MANIPULATED, AND THE EPICARDIAL PACING WIRES REMAINED INTACT ON THE SKIN. IT WAS IMMEDIATELY TURNED ON, AND THE EMERGENCY MODE WAS EMPLOYED WITHOUT INCIDENT. THE PATIENT IMMEDIATELY REGAINED CONSCIOUSNESS, HAD NO ILL EFFECTS, RECOVERED HER BLOOD PRESSURE WITHOUT REQUIRING VASOPRESSORS, AND WAS COMPLETELY A + OX3 (ALERT & ORIENTED TO PERSON, PLACE, AND TIME). THE DEVICE WAS SWITCHED TO A NEW ONE, WITH A NEW BATTERY. SINCE THE INCIDENT, THE PATIENT HAS NOT HAD ANY DIFFICULTY PACING. NO FURTHER 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 Required Intervention