BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1881250 · Received October 6, 2010

    Report

    Report Number
    1627487-2010-02768
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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) 2010, THE PT'S SCS SYSTEM WAS REVISED AND SHE WAS IMPLANTED WITH A NEW IPG. ON (B)(6) 2010, THE PT TURNED HER STIMULATION OFF BEFORE GOING TO BED. WHEN SHE ATTEMPTED TO TURN THE IPG BACK ON THE NEXT MORNING ((B)(6) 2010), THE PROGRAMMER SHOWED A COMMUNICATION ERROR. SHE THEN TRIED THE CHARGER AND IT WOULD NOT LOCATE THE IPG EITHER. THE PT MET WITH CLINICAL SPECIALIST WHO VERIFIED THAT THE PROGRAMMER CHARGER WOULD NOT COMMUNICATE WITH THE IPG. THE BATTERIES WERE CHANGED IN THE PROGRAMMER AND THE CHARGER WAS FULLY CHARGED. BOTH THE WAND AND CHARGER ANTENNA WERE MOVED ALL AROUND THE IPG AND PRESSED DOWN ON AND MOVED AWAY FROM THE IPG. AN X-RAY WAS TAKEN AND EVERYTHING LOOKED OKAY. A REPLACEMENT CHARGER WAS SENT BUT IT ALSO WOULD NOT COMMUNICATE. THE PT RECENTLY LOST OVER (B)(6) BUT THAT WAS BEFORE THE REVISION IN (B)(6). THE PT IS MEETING WITH HER DOCTOR TO DISCUSS ANOTHER BATTERY REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2887102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other