BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 2791360 · Received October 15, 2012

    Report

    Report Number
    2647346-2012-01704
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    June 1, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1516-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND 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 PATIENT BEGAN TO FEEL FATIGUED AND HAD A SYNCOPAL EPISODE AFTER EXPERIENCING A BLUNT TRAUMA TO THE DEVICE. THE LEADS WERE FOUND TO HAVE HIGH IMPEDANCE. THE PATIENT ELECTED TO HAVE THE SYSTEM EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R