BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1895457 · Received November 4, 2010

    Report

    Report Number
    1627487-2010-03515
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 SPECS AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE IPG FOUND DISCOLORATION ON THE HEADER AND THE CAN. IN ADDITION, THE CAN WAS DENTED ON THE BACKSIDE AND SCRATCHES ON THE HEADER WERE PRESENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE DEVICE WAS RECEIVED WITH NO OUTPUT OR TELEMETRY. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2010-03516. IT WAS REPORTED THE PT HAD AN SCS SYSTEM WHICH INCLUDED AN IPG. AFTER YEARS OF NOT USING OR RECHARGING HER IPG, THE PT ATTEMPTED TO TURN ON THE SCS THERAPIES. NEITHER THE PT PROGRAMMER OR DEVICE CHARGING SYSTEM WOULD COMMUNICATE WITH THE IPG. AN X-RAY OF THE SCS SYSTEM WAS TAKEN. THE X-RAY REVEALED THAT ONE OF THE PT'S LEADS HAD MIGRATED. ACCORDING TO THE PT'S ACCOUNT OF HER MEDICAL HISTORY, SHE DOES HAVE A HISTORY OF FALLS. THE IPG WAS EXPLANTED AND REPLACED WHILE THE LEAD WAS REPOSITIONED AND REUSED. THE EXPLANTED IPG WAS RETURNED TO THE MFR FOR ANALYSIS. FOLLOW UP ON THE PT FOUND THAT SHE IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 38755A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention