BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI-IPG

    MDR report key: 1852331 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02722
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE PATIENT COMPLAINED OF AN ISOLATED INCIDENT OF SHOCKING AT THEIR IPG SITE. THE SJM REP MET WITH THE PATIENT AND PERFORMED SOME REPROGRAMMING AND RAN AN IMPEDANCE CHECK. ALL CONTACTS WERE BETWEEN 379-652 OHMS. A WEEK LATER, THE PATIENT SAID THAT THE SHOCKING AT THE IPG SITE HAD INCREASED IN FREQUENCY AND HAD BECOME UNBEARABLE. THE SENSATIONS OCCURRED WHETHER THE SYSTEM WAS TURNED ON OR OFF. THE PATIENT ALSO SAID THAT CHANGING BODY POSITIONS DIDN'T MAKE A DIFFERENCE IN RELIEVING THE PAIN. THE PATIENT HAS BEEN TURNING THE SYSTEM OFF WITH THERE MAGNET SO, THE SJM REP INSTRUCTED THE PATIENT TO TURN THE STIMULATOR OFF USING THE PROGRAMMER. THE SJM REP ALSO REFERRED THE PATIENT TO AN MD FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI-IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2804836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other