BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110796 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02625
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    July 1, 2012
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 2. REFERENCE MFR REPORT: 1627487-2013-02626. IT WAS REPORTED THE PT'S SCS SYSTEM DID NOT PROVIDE ADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING EFFORTS. THE PT REPORTED SHE FELT RANDOM ELECTRICAL PULSES DOWN HER LEFT ARM AND LEG WHEN STIMULATION WAS ON. THE PT ALSO REPORTED DIFFICULTY CHARGING HER IPG. SHE STATED THE IPG WOULD NOT HOLD A CHARGE AFTER IT INDICATED IT WAS FULLY CHARGED, AND EVENTUALLY, SHE COULD NOT GET HER IPG TO CHARGE AT ALL. CONSEQUENTLY, SHE HAD HER SYSTEM EXPLANTED IN (B)(6) 2013. THE EXACT EXPLANT DATE IS CURRENTLY UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204811 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3890612

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3383 (2)