BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 2813408 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02454
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CLINIC VISIT, IT WAS NOTED THAT THERE WAS NO PACING OUTPUT ON THE VENTRICULAR LEAD. THE X-RAY EXAMINE FOUND THE LEAD TO BE COMPLETE, SO PHYSICIAN DECIDED TO OPEN THE POCKET. ONCE THE POCKET WAS OPEN, THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT CONNECTED TIGHTLY TO THE LEAD. THE CONNECTION WAS TIGHTENED AND THE DEVICE REMAINS IN USE. 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 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SDR303

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R