BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2772013 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-02401
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 10, 2012
    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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-02402. THE PATIENT RECEIVED TWO LEADS (FROM THE SAME LOT) AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PATIENT FELT A SHOCKING SENSATION OR OVERSTIMULATION AT THE IPG POCKET SITE. THE PATIENT DENIED ANY TRAUMA OR INJURY TO THE SITE. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS FOR MULTIPLE LEAD CONTACTS. ALLEGEDLY REPROGRAMMING WAS UNABLE TO PROVIDE STIMULATION COVERAGE WITHOUT THE PATIENT FEELING UNCOMFORTABLE POCKET STIMULATION. THE PHYSICIAN PLANNED TO EXPLANT AND REPLACE THE PATIENT'S SCS SYSTEM ON (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 116319

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention