BEUDAMED
    FDA Adverse Event Death Summary report: N

    GENESISXP- CONVENTIONAL IPG

    MDR report key: 1793620 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01883
    Event Type
    Death
    Date Received
    August 6, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: TESTED FOR COMMUNICATION WITH PT PROGRAMMER FAILED. COMMUNICATIONS ERROR 2500. IPG FAILS THE "WAKE UP" ROUTINE. VISUAL AND FUNCTIONAL INSPECTION WAS COMPLETED. CONCLUSION: THE COMPLAINT ABOUT: "PT DIED. IT WAS NOT DEVICE RELATED." CANNOT BE CONFIRMED; THE IPG AS RECEIVED IS NON FUNCTIONAL. THE PRODUCT CANNOT BE ANALYZED BECAUSE OF A LACK OF PERTINENT INFO ON IMPLANT/EXPLANT DATES AND PT PROGRAM PARAMETERS. ANS HAS LIMITED INFO RELATED TO THE PT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT¿S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6)2005, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT EXPIRED AT THE VA HOSPITAL. THE HOSPITAL STAFF STATED THAT THE DEATH WAS NOT DEVICE RELATED. THE HOSPITAL STAFF IS RETURNING PRODUCT TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP- CONVENTIONAL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3609 36116A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O