BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON-IPG

    MDR report key: 1790220 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01882
    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 Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: IPG COMMUNICATES WITH A LAB PPG. VISUAL INSPECTION REVEALS SCRATCHES ON IPG HEADER AND CAN. INSTRUMENT MARKS ON THE HEADER, INSTRUMENT MARKS ON THE SILICONE ANTENNA COVER, INSTRUMENT MARKS ON THE REAR OF THE CAN, UPPER SETSCREW FOUND OUT OF THE CONNECTOR BLOCK UNDER THE SEPTUM. NO OTHER VISIBLE ANOMALIES WERE NOTED. THE DEVICE WAS TESTED FOR COMMUNICATION WITH PT PROGRAMMER AND PASSED. CONCLUSION: THERE WAS NO COMPLAINT AGAINST THE IPG. THE IPG PASSED AUTO TEST. NO CONCLUSION COULD BE MADE ABOUT THE CORRELATION OF THE IPG AND THE PT'S DEATH. 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)2008, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT EXPIRED IN THE VA HOSPITAL. IT WAS NOT DEVICE RELATED. IPG WAS EXPLANTED AND HOSPITAL STAFF WOULD LIKE TO RETURN THE PRODUCT BACK TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON-IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 118326

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O