BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND 3

    MDR report key: 1875534 · Received October 19, 2010

    Report

    Report Number
    6000094-2010-02093
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 21, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S4
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

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

    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) DID NOT MEET EXPECTED LONGEVITY, CAUSE UNKNOWN. BOTH STATIC AND DYNAMIC PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE AT BOL (BEGINNING OF LIFE) VOLTAGES. THERE IS NO EVIDENCE TO INDICATE A PROBLEM WITH THE BATTERY. WITHOUT KNOWING THE PROGRAMMING HISTORY OF THIS DEVICE THERE IS NO WAY TO DETERMINE WHY IT DID NOT MEET ITS EXPECTED LONGEVITY CALCULATION. IT WAS ALSO FOUND THAT THE WIRE BONDS LIFTED. THIS WAS NOTED TO HAVE OCCURRED POST EXPLANT. ADVERSE EVENT FLAG, DATE OF DEATH FIELD IS 'NOT APPLICABLE', PATIENT OUTCOME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LONGEVITY OF THE PACEMAKER WAS TOO SHORT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND 3 ASKU DXY MEDTRONIC S.A. 840 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R