BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 DR

    MDR report key: 2202822 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01084
    Event Type
    Death
    Date Received
    August 11, 2011
    Date of Event
    July 26, 2004
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) AND A TWO LEADS WERE RETURNED A FUNERAL HOME WITH NO INFORMATION APPROXIMATELY SEVEN YEARS AFTER THE DEATH. INFORMATION IDENTIFIED IN THE MANUFACTURE DATA BASE INDICATED THE PATIENT DIED SIX MONTHS AFTER THE IMPLANT OF THE IPG SYSTEM. CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death