BEUDAMED
    FDA Adverse Event Death Summary report: N

    EONC 16-CHANNEL IPG

    MDR report key: 1783747 · Received July 28, 2010

    Report

    Report Number
    1627487-2010-01476
    Event Type
    Death
    Date Received
    July 28, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, ANS WAS INFORMED THAT THE PATIENT DIED. THE IMPLANTING PHYSICIAN WAS CONTACTED AND STATED THAT HE WAS UNAWARE OF THE CAUSE OF DEATH. THE DOCTOR ALSO MENTIONED THAT THE PATIENT DID NOT HAVE ANY KNOWN OR OBVIOUS COMPLICATIONS WITH THE SCS SYSTEM. ANS ALSO CONTACTED THE PATIENT'S PRIMARY PHYSICIAN BUT WAS UNABLE TO RECEIVE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3688 3121547

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O