BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 200 DR

    MDR report key: 2101263 · Received May 24, 2011

    Report

    Report Number
    6000144-2011-02080
    Event Type
    Death
    Date Received
    May 24, 2011
    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
    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 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.

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR WAS RETURNED AFTER A PATIENT DEATH WITH NO INFORMATION AND HAS TESTED OUT OF SPECIFICATIONS. NO EVIDENCE SUGGESTS THAT THE DEVICE WAS RELATED TO THE PATIENT'S DEATH. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN MADE IN REGARDS TO THE DEVICE. THE DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 6 YEARS 4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 200 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR203 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death| O 4076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD