BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4143019 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-08311
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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 2 OF 2. REF. MFR REPORT # 1627487-2014-08310. IT WAS REPORTED, THE PT'S SCS SYSTEM STIMULATION HAD CHANGED ON (B)(6) 2014 AND WAS NOW CAUSING STIMULATION IN THE WRONG LOCATION. THE PT HAS REPORTEDLY HAD MULTIPLE FALLS SINCE HER PERMANENT IMPLANT PROCEDURE ON (B)(6) 2013. IT WAS DETERMINED ONE OF THE PT'S SCS LEADS HAD MIGRATED. AS IT IS UNK WHICH LEAD IS ASSOCIATED WITH THE REPORTED ISSUE, ALL POSSIBLE LEADS ARE BEING REPORTED. ADDITIONAL INFO RECEIVED IDENTIFIED BOTH OF THE PT'S LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2014. THE PT REPORTEDLY HAS EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591040 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3994303

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANT DATE| IMPLANT DATE| SCS IPG, MODEL 3788| SCS ANCHOR, MODEL 1192 (X2)