BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3810543 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-21288
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 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

    THE PT RECEIVED TWO SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED A CHANGE IN STIMULATION LAST WEEK, AND SUBSEQUENTLY LOST STIMULATION. DIAGNOSTICS REVEALED MULTIPLE INVALID CONTACTS. REPROGRAMMING WAS UNSUCCESSFUL. X-RAYS CONFIRMED THE PT'S LEFT LEAD HAD MIGRATED. SURGICAL INTERVENTION WILL BE TAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271736 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4037113

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE: