BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 SR

    MDR report key: 2812254 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02341
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    September 26, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1512-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA WERE ALSO COLLECTED FROM THE DEVICE AND ANALYZED. THERE WAS UNDEFINED RESISTANCE NOTED ON THE PACING IMPEDANCE MEASUREMENT FOR THE RIGHT VENTRICULAR LEAD.

    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): THE DEVICE WAS RETURNED AND ANALYZED. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED OUTPUT BOND WIRES.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED DUE TO THE FIELD ADVISORY. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 SR PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY MEDTRONIC S.A. SSR303

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R