BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 VDD

    MDR report key: 1663229 · Received April 21, 2010

    Report

    Report Number
    2647346-2010-00142
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    December 5, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1510/1519-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. 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. EVALUATION SUMMARY (B) (4) PRELIMINARY TESTING REVEALED NO OUTPUT AND NO TELEMETRY. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 VDD IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SVDD303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other