BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 DR

    MDR report key: 2071180 · Received April 27, 2011

    Report

    Report Number
    6000144-2011-02055
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    December 21, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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): THE PATIENT DIED ON (B)(6) 2009 AND THE DEVICE WAS EXPLANTED AND RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. THE DEVICE WAS ANALYZED AND PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES. THE EXPLANT DATE IS UNKNOWN AND FURTHER ANALYSIS REVEALED THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR ON (B)(6) 2011 APPROXIMATELY TWO YEARS AFTER THE PATIENT'S DEATH AND NO ANOMALIES WERE FOUND. CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. THE PATIENT DIED APPROXIMATELY FIVE YEARS FROM PACEMAKER IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.

    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 87 YR Death 4524 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD