BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110865 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-00256
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PT (B)(6) EXPERIENCED A FALL AND LOST THE ABILITY TO INCREASE THE AMPLITUDE FOR HER STIMULATION. A DIAGNOSTIC TEST REVEALED IMPEDANCE ISSUES FOR SEVERAL LEAD CONTACTS. EFFORTS TO RECAPTURE EFFECTIVE STIMULATION VIA REPROGRAMMING WERE UNSUCCESSFUL. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEAD. THERAPY WAS RESTORED FOR THE PT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204989 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 67289

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS EXTENSION: MODEL 3386