BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1800726 · Received August 12, 2010

    Report

    Report Number
    1627487-2010-01498
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. DEVICE SETTINGS WERE EXAMINED TO DETERMINE IF THE CAUSE WAS NORMAL BATTERY DEPLETION. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. NORMAL BATTERY DEPLETION COULD NOT BE CONFIRMED. CONCLUSION: 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 WAS IMPLANTED WITH AN SCS SYSTEM. THE PT EXPERIENCED DIFFICULTY WITH THE CHARGER LOCATING THE IPG, AND WAS SENT A REPLACEMENT CHARGER. THE REPLACEMENT WOULD NOT LOCATE THE IPG EITHER. THE IPG WAS EXPLANTED ON (B)(6) 2010 AND REPLACED.

    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 2867471

    Patients

    Seq Age Sex Outcome Treatment
    1 Other