BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2143101 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-03145
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. 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 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 6. REFERENCE MFR REPORT 1627487-2011-03146, 03147, 03117, 03119, 03123. THE PT REC'D A SCS SYS INCLUDING AN IPG, THREE PERCUTANEOUS LEADS ( FROM 2 SEPARATE LOTS), AN EXTENSION AND LEAD ANCHOR, ON (B)(6) 2011. IT WAS REPORTED THAT THE DEVICE WERE EXPLANTED ON (B)(6) 2011 DUE TO A (B)(6) INFECTION. THE PT WAS TREATED WITH ORAL ANTIBIOTICS AND WOUND CARE. F/U ON THE PT FOUND THAT THE INFECTION HAS RESOLVED, BUT THE PT IS CONTINUING WITH A WOUND CARE REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3269298

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention