BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2489419 · Received March 8, 2012

    Report

    Report Number
    1627487-2012-08535
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULT - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3: REFERENCE MFR REPORT - 1627487-2012-08536 AND 1627487-2012-08537. IT WAS REPORTED THAT THE SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE OCCIPITAL (OFF LABEL) LEAD HAD (B)(6) INFECTION. F/U INDICATED THAT THE PT WAS SEEN BY THE PHYSICIAN AND WAS DOING WELL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3504573

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention