BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 100 S

    MDR report key: 2173938 · Received July 24, 2011

    Report

    Report Number
    2182208-2011-01068
    Event Type
    Death
    Date Received
    July 24, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE PULSE GENERATOR DIED APPROXIMATELY ELEVEN MONTHS AFTER IMPLANT TWELVE YEARS AGO. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 100 S IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC, INC. SS103 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death