BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1892146 · Received October 26, 2010

    Report

    Report Number
    1627487-2010-03046
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED 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. SJM HAS LIMITED INFORMATION 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

    THE PT RECEIVED HER SCS SYS, INCLUDING AN IPG ON (B)(6) 2010. IT WAS REPORTED, THE IPG WILL BE EXPLANTED AND REPLACED DUE TO A LOSS OF STIMULATION. THE IPG WAS REPORTED TO BE DIFFICULT TO CHARGE AS THE CHARGER COULD NOT LOCATE THE IPG. AS A RESULT, THE PT WAS NONCOMPLIANT WITH THE DEVICE CHARGING REQUIREMENTS. THE PHYSICIAN NOTED, THE PT HAS LOST A SIGNIFICANT AMOUNT OF WEIGHT SINCE IMPLANT AND THE IPG HAS SHIFTED TO AN ANGLED POSITION WITHIN THE IPG POCKET. THE PHYSICIAN PLANS TO REPLACE THE CURRENT IPG WITH A NON-RECHARGEABLE MODEL. IT IS CURRENTLY UNK IF THE IPG WILL BE RETURNED TO THE MFR FOR ANALYSIS AFTER IT IS EXPLANTED. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3143583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention