BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 954002 · Received November 21, 2007

    Report

    Report Number
    1627487-2007-00024
    Event Type
    Other
    Date Received
    November 21, 2007
    Date of Event
    October 16, 2007
    Report Date
    November 21, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSIONS: EXPLANTS WERE SENT TO A PATHOLOGY LABORATORY AND HAVE NOT BEEN RETURNED TO ANS FOR EVALUATION. ANS INC. CORPORATION HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS INC. CORPORATION DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH HER SCS SYSTEM IN 2007. MONTHS LATER, SHE REPORTED DEVELOPING A SENSITIVITY TO TOUCH AND PRESSURE IN THE IPG POCKET AREA. SHE WAS EVALUATED FOR A POSSIBLE INFECTION IN THAT AREA, BUT THERE WAS NONE FOUND. THE PT ALSO REPORTED TINNITUS SYMPTOMS WHEN THE IPG WAS TURNED ON, AND SHE ALSO REPORTED FEELING PERIODIC SHOCKING SENSATIONS IN THE IPG POCKET AREA, WHETHER OR NOT THE DEVICE WAS TURNED ON. THE PT'S SYSTEM WAS EXPLANTED IN 2007. PER HOSPITAL PROTOCOL, THE EXPLANTED DEVICES WERE SENT TO THE PATHOLOGY LABORATORY WHICH HAS NOT RELINQUISHED THEM TO BE SENT BACK TO ANS FOR EVALUATION. IF THE DEVICES ARE RETURNED TO ANS FOR EVALUATION A FOLLOW-UP REPORT WILL BE SUBMITTED. FOLLOW-UP WITH THE PT FOUND THAT THE ACUTE TENDERNESS AT THE IPG SITE IS RESOLVING, AND THE TINNITUS SYMPTOMS COME AND GO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR IMPLANTABLE PULSE GENERATOR GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 64044

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other