BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2051072 · Received April 5, 2011

    Report

    Report Number
    1627487-2011-00460
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00461. THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2010, INCLUDING AN IPG AND A SURGICAL LEAD. IT WAS REPORTED THAT THE PT LOST THERAPY COVERAGE OF HER BIG TOE AND PART OF HER FOOT. EFFORTS TO RESOLVE THIS MATTER VIA REPROGRAMMING WERE UNSUCCESSFUL. SURGICAL INTERVENTION WAS UNDERTAKEN WITH THE INTENT OF REPLACING THE PT'S ORIGINAL SURGICAL LEAD WITH A DIFFERENT MODEL TO ACHIEVE BETTER COVERAGE. HOWEVER, DUE TO THE PRESENCE OF SCAR TISSUE, THE PHYSICIAN EXPERIENCED DIFFICULTY PLACING THE LEAD AND CAPTURING OPTIMAL STIMULATION COVERAGE FOR THE PT. PLACEMENT OF A PERCUTANEOUS LEAD WAS ALSO ATTEMPTED TO NO AVAIL. DUE TO THE INABILITY TO CAPTURE EFFECTIVE STIMULATION COVERAGE DURING THE PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THE PATIENT'S ENTIRE SCS SYSTEM.

    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 DIV 3788 3101644

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention