BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 D

    MDR report key: 1072233 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00316
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 5, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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: TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS, WHICH WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCE (GREATER THAN 9999 OHMS). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT STATUS FOLLOWING THE REPLACEMENT PROCEDURE WAS REPORTED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 D IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SD303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention