BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4842252 · Received June 12, 2015

    Report

    Report Number
    1627487-2015-23332
    Event Type
    Injury
    Date Received
    June 12, 2015
    Report Date
    June 19, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS/REMOVAL REPORTING NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. (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.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THE PATIENT HAS NOT USED OR CHARGED HER SCS SYSTEM IN OVER A YEAR. IT WAS ALSO REPORTED THE PATIENT'S IPG IS NOT FUNCTIONAL AND THE PATIENT IS WITHOUT STIMULATION. THE PATIENT IS UNABLE TO LOCATE HER EXTERNAL DEVICES. THE PATIENT MAY UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION. THE EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION REVEALED THE SURGEON DECIDED TO TRY NON-SURGICAL INTERVENTIONS TO TREAT THE PATIENT'S PAIN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385519 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3208617

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3228 SCS LEAD