BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961197 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-21484
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 17, 2014
    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

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-002-R. 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

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE IPG USING THE CHARGING SYSTEM. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT WHICH RESOLVED THE COMMUNICATION ISSUE, HOWEVER; IT WAS REPORTED THE IPG STARTED "STUTTERING" AND THE PATIENT WAS UNABLE TO CHARGE THE IPG. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE TO EXPLANT AND REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413255 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 172558

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS LEAD, MODEL: 3186 (3)