BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2131606 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00301
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT. EVALUATION SUMMARY (B)(4) - ANALYSIS COULD NOT CONFIRM THE CUSTOMER ALLEGATION. ANALYSIS DID FIND THAT THE BATTERY RELEASE WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, AND THE BATTERY DRAWER WAS BROKEN. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING AND SIDE BAIL COVERS WERE BROKEN AND THE RING BAIL WAS MISSING.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 CUSTOMER ALLEGATION. ANALYSIS DID FIND THAT THE BATTERY RELEASE WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, AND THE BATTERY DRAWER WAS BROKEN. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING AND SIDE BAIL COVERS WERE BROKEN AND THE RING BAIL WAS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT TURNED ITSELF OFF WHILE "DPD" PACING, THEN RESET ITSELF BACK TO DEFAULT SETTINGS. THE BATTERY INDICATOR WAS NOT FLASHING. NO PATIENT INVOLVEMENT OR 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 Other