BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 D

    MDR report key: 2790854 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02105
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1514-2009
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE NO OUTPUT CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH DIZZINESS, CIRCULATION PROBLEMS AND ATRIAL/VENTRICULAR BLOCK II/III. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS NOT ABLE TO PACE AND HAD NO OUTPUT. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER 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 D IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SD303

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R