BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2010588 · Received March 1, 2011

    Report

    Report Number
    1627487-2011-00275
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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 2. REFERENCED MFR. REPORT# 1627487-2011-00276. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG AND PERCUTANEOUS LEAD; A SECOND LEAD WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PT'S SCS WAS EXPLANTED ON (B)(6) 2011 DUE TO AN INFECTION AT THE LEAD SITE. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AS TREATMENT, AND THE PT WAS REFERRED TO AN INFECTION DISEASE PHYSICIAN FOR FURTHER EVAL. FOLLOW-UP ON THE PT FOUND THAT SHE IS RECOVERING WELL.

    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 DIVISION 3788 2887104

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention