BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 VDD

    MDR report key: 1926442 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02319
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 8, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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) PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET (POR). THE PATIENT HAD EXPERIENCED A PREVIOUS POR AFTER EXTERNAL CARDIOVERSION A YEAR AGO. THE PHYSICIAN WAS NOT ABLE TO USE THE "FIND PATIENT" FUNCTION AND NEEDED TO OPEN THE SIGMA SERIES SOFTWARE MANUALLY. THE PHYSICIAN CLEARED THE POR, PERFORMED THE FOLLOW UP, AND ENDED THE SESSION. WHEN THE PHYSICIAN TRIED TO "FIND PATIENT" AGAIN, THE SAME ERROR MESSAGE OCCURRED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 VDD IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SVDD303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R