BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2555953 · Received April 26, 2012

    Report

    Report Number
    1627487-2012-08767
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 4, 2012
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 RELATED TO THIS EVENT 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

    DEVICE 1 OF 4. REFERENCE MFR REPORT: 1627487-2012-08768. REFERENCE MFR REPORT: 1627487-2012-08769. REFERENCE MFR REPORT: 1627487-2012-08770. IT WAS REPORTED THAT THE SURGICAL WOUND IN THE PT'S BACK WAS OPENED AND THE ANCHOR WAS VISIBLE. THE PHYSICIAN SUGGESTED THE PT'S DIABETES AND ASSOCIATED DIMINISHED HEALING RESPONSE WERE THE POSSIBLE CAUSE OF THE ISSUE. THE ENTIRE SYSTEM WAS EXPLANTED. THE FACILITY RETAINED THE DEVICES. 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 MED - NEUROMODULATION 3788 3535759

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention