BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3926037 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-25458
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    March 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER IS INCLUDED IN FIELD ADVISORIES. 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 PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2014-25459 AND 25460. THE PT HAS A CERVICAL AND THORACIC SCS SYSTEM. THE EVENT IS RELATED TO THE PT'S CERVICAL SCS SYSTEM. IT WAS REPORTED, THE PT WAS NOT RECEIVING STIMULATION DUE TO EXPERIENCING A FALL TWO MONTHS AGO. REPROGRAMMING ATTEMPTS DID NOT PROVIDE EFFECTIVE COVERAGE. DIAGNOSTIC REVEALED LOW IMPEDANCES. THE PT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353760 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3079783

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other IMPLANT DATE:| SCS ANCHORS: MODEL 1192 (X2)