BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2120956 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00792
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO CANTED BAL-SEAL SPRINGS IN THE LOWER HEADER PORT (CHANNEL 1-8). THE PT PROGRAM RETRIEVED FROM THE IPG INDICATED THE LOWER PORT WAS USED AND THE UPPER PORT WAS NOT USED. IT CANNOT BE DETERMINED WHEN THE BAL-SEAL SPRINGS WERE DAMAGED OR IF THEY CONTRIBUTED TO THE REPORTED EVENT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS SERIAL NUMBER WAS PART OF A FIELD ADVISORY. 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 AN SCS SYS INCLUDING AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT HER IPG WAS REPLACED ON (B)(6) 2011 DUE TO THE DEVICE TURNING BOTH ON AND OFF WITHOUT PROMPTING. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3083995

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3219