BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 4801762 · Received May 28, 2015

    Report

    Report Number
    1627487-2015-15185
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 11, 2006
    Report Date
    May 5, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION 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

    A REVIEW OF THE PATIENT'S MEDICAL RECORD WAS PERFORMED AND NOTED THE FOLLOWING: FROM (B)(6) 2006 - (B)(6) 2008 THE PATIENT EXPERIENCED DISCOMFORT OVER THE IPG SITE AS IT PROTRUDED OVER THE POSTERIOR ILIAC CREST AREA. THE PATIENT STATED DUE TO THE LOCATION THE IPG WAS PAINFUL ESPECIALLY WHEN SHE WOULD LIE BACK ON IT. THE PATIENT'S SCS SYSTEM WAS EXPLANTED AND REPLACED ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345677 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 R47788

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other MODEL 3186 (2), SCS LEAD