BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MNI

    MDR report key: 3564016 · Received October 25, 2013

    Report

    Report Number
    1627487-2013-17532
    Event Type
    Injury
    Date Received
    October 25, 2013
    Date of Event
    September 27, 2013
    Report Date
    October 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-17533. THE PATIENT HAS 2 SCS SYSTEMS. IT WAS REPORTED THE PATIENT IS UNABLE TO ESTABLISH COMMUNICATION WITH THE SCS IPG IMPLANTED FOR HIS BACK PAIN USING HIS CHARGING SYSTEM AND PATIENT PROGRAMMER AS THE PROGRAMMER WAS DISPLAYING A COMM ERROR 2501 MESSAGE. IT WAS ALSO REPORTED THE PATIENT LOST BACK STIMULATION IN ADDITION TO LOSING THE ABILITY TO TURN ON THE IPG USING HIS MAGNET. MOREOVER, IT WAS REPORTED THE ISSUES POSSIBLY BEGAN AFTER THE PATIENT FELL OUT OF HIS RECLINER (PATIENT WAS HOSPITALIZED AND RECEIVED PAIN MEDICATION). AS OF (B)(6) 2013, THE PATIENT LOST THE ABILITY TO COMMUNICATE WITH THE SCS IPG IMPLANTED FOR HIS NECK PAIN AND SUBSEQUENTLY LOST NECK STIMULATION. THE ISSUE DID NOT RESOLVE WITH A REPLACEMENT CHARGING SYSTEM. SUBSEQUENTLY, SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550120 EON MNI GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2761931

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other GZB: MODEL 3382| GZB: MODEL 1191| GZB: MODEL 3146 (2)| GZB: MODEL 3189 (2)| IMPLANT DATE:| GZB: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| GZB: MODEL 3186| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE: