BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 5145775 · Received October 13, 2015

    Report

    Report Number
    1627487-2015-01362
    Event Type
    Injury
    Date Received
    October 13, 2015
    Report Date
    March 15, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    ADDITIONAL INFORMAITION RECEIVED IDENTIFIED THE PATIENT'S SCS IPG WAS REPLACED WITH A NEW ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DOES NOT HAVE ANY STIMULATION THERAPY AND SHE WAS UNABLE TO COMMUNICATE WITH HER SCS IPG AND EXTERNAL DEVICES. THE PATIENT STATED SHE HAS NOT CHARGE HER SCS IPG IN MORE THAN SIX MONTHS. A SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676955 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3410795

    Patients

    Seq Age Sex Outcome Treatment
    1 Other