BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032342 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-02445
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 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 5 OF 5. REFERENCE MFR REPORTS: 1627487-2013-02441, 02442, 02443 AND 02444. THE PT HAS FOUR LEADS (FROM THREE LOTS) AND TWO EXTENSIONS (FROM THE SAME LOT). IT WAS REPORTED THE PT'S SCS SYSTEM WAS AUTO-REDUCING. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. AN X-RAY SHOWED ONE OF THE LEAD EXTENSIONS HAD PULLED OUT OF THE IPG HEADER. F/U INDICATED MORE LEAD CONTACTS HAD INVALID IMPEDANCE MEASUREMENTS. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE. AS THE AFFECTED LEADS AND EXTENSIONS ARE UNK, ALL OF THE PT'S DEVICES ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131177 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3873320

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR