BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 4113296 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-25619
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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

    IT WAS REPORTED THE PATIENT'S (B)(6) STIMULATION WAS TURNING OFF EVERY FEW HOURS. PREOPERATIVE DIAGNOSTICS REVEALED NO ANOMALIES. IN TURN, THE PHYSICIAN DECIDED TO PERFORM SURGICAL INTERVENTION TO ADDRESS THE ISSUE. DURING THE PROCEDURE THE PHYSICIAN EXPLANTED AND REPLACED THE IPG AFTER DIAGNOSTIC TESTING. EFFECTIVE STIMULATION WAS RESTORED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577072 EONC GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 4271917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCS LEAD, MODEL: UNKNOWN