BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4202015 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-26851
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 19, 2014
    Report Date
    September 25, 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
    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. REF MFR REPORT: 1627487-2014-26857. IT WAS REPORTED THE PT IS EXPERIENCING OVERSTIMULATION IN THE GROIN AREA; HOWEVER, IS NOT RECEIVING STIMULATION ON THE LEFT SIDE. LEAD DIAGNOSTICS REVEALED MULTIPLE LOW IMPEDANCES. REPROGRAMMING WAS INITIALLY ABLE TO RESOLVE THE ISSUE. FOLLOW UP INFO IDENTIFIED THE PT CONTINUED TO EXPERIENCE OVERSTIMULATION AND INEFFECTIVE STIMULATION. AN X-RAY WAS TAKEN AND CONFIRMED ONE OF THE LEADS HAD MIGRATED. THE PT UNDERWENT SURGICAL INTERVENTION TO REMOVE AND REPLACE THE LEADS. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663316 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4292301

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS ANCHOR, MODEL 1192 (2),| SCS IPG, MODEL 3788,| IMPLANT DATE:| IMPLANT DATE: