BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 100 VVI

    MDR report key: 1792547 · Received August 11, 2010

    Report

    Report Number
    6000024-2010-00045
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    March 9, 2010
    Manufacturer
    MEDTRONIC OF CANADA LTD.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1510/1519-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. THE EVENT OCCURRED OUTSIDE THE US. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) PRELIMINARY TESTING REVEALED NO OUTPUT AND NO TELEMETRY. THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED PREVENTIVELY 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 100 VVI IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC OF CANADA LTD. SVVI103 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other