BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192100 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02857
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-02856. THE PATIENT HAS TWO SCS SYSTEMS (CERVICAL AND THORACIC), AND SHE RECEIVED TWO LEADS FROM THE SAME LOT AS PART OF HER THORACIC SYSTEM. IT WAS REPORTED THE PATIENT WAS UNABLE TO INCREASE THE AMPLITUDE OF HER THORACIC SYSTEM STIMULATION DUE TO AUTO-REDUCING. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCES FOR ONE LEAD, AND THE OTHER LEAD SHOWED LOW IMPEDANCE READINGS. AN X-RAY SHOWED THE LEADS CONTACTS WITH LOW IMPEDANCES APPEARED TO BE DISCONNECTED FROM THE IPG. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYSTEM, THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281071 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 4049356

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other SCS LEAD: MODEL 3189| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE: