BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 D

    MDR report key: 1072037 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00299
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 1, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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. THIS DEVICE IS PART OF THE FIELD ACTION FOR THIS MODEL AND TESTED OUT OF SPECIFICATION CONSISTENT WITH THE ADVISORY. EVALUATION SUMMARY: TESTING REVEALED NO OUTPUT AND NO TELEMETRY. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LOSS OF TELEMETRY, NO OUTPUT AND PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 D IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SD303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention