BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1910880 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03325
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT PT COMPLAINED OF PAIN AT THE IMPLANT SITE. THE PHYSICIAN REVISED THE IPG POCKET AND MOVED IT TO THE PT'S FLANK. AS THE PRODUCT WAS NOT EXPLANTED, NO RETURN IS EXPECTED. FOLLOW UP ON THE PT FOUND THAT PAIN AT THE ORIGINAL POCKET SITE HAS RESOLVED AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2874316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention