BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1925641 · Received December 14, 2010

    Report

    Report Number
    2183613-2010-00323
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 5, 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
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. IT WAS NOTED THAT THE SCREW ON THE CASE WAS OVER-TIGHTENED, MAKING IT VERY HARD TO CLOSE THE BATTERY COMPARTMENT. THE COMPRESSED BATTERY CONTACTS, RING, AND O-RING WERE PREVENTATIVELY REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ADMITTING A PATIENT TO CVICU POST-PROCEDURE, A SUDDEN LOSS OF CAPTURE WAS NOTED ON THE CARDIAC MONITOR, AND NO ELECTRICAL ACTIVITY WAS NOTED ON THE EPG (EXTERNAL PULSE GENERATOR). ANOTHER DEVICE WAS APPLIED, AND ELECTRICAL ACTIVITY/CAPTURE WAS ACHIEVED. THE BATTERY WAS EXAMINED BY THE RN, UTILIZING A BATTERY TESTER, AND WAS NOTED TO BE OK. THE BIOMEDICAL ENGINEER PERFORMED FULL FUNCTIONAL TESTS, INCLUDING LONG-TERM TESTING WITH THE BATTERY IN QUESTION, WITH NO ANOMALIES FOUND. THERE WERE NO PATIENT COMPLICATIONS 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