BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3142113 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-04644
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    August 29, 2012
    Report Date
    May 2, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 INFO 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 3. REF MFR REPORTS: 1627487-2013-04643 AND 04675. IT WAS REPORTED THE PT HAD STIMULATION, BUT IT WAS NOT PROVIDING FULL STIMULATION COVERAGE. THE PT HAD BEEN REPROGRAMMED MULTIPLE TIMES, AND EACH TIME RECEIVED EFFECTIVE STIMULATION IMMEDIATELY AFTER THE APPOINTMENT. IT WAS REPORTED THE PT HAD STIMULATION BUT WAS NOT SATISFIED WITH THE RELIEF PROVIDED. MULTIPLE CONTACTS HAD INVALID IMPEDANCES. X-RAYS DID NOT REVEAL ANY ANOMALIES, BUT IT WAS REPORTED THE SYSTEM WAS AUTO-REDUCING. F/U IDENTIFIED THE PHYSICIAN REPLACED BOTH LEADS AND THE IPG. IT WAS REPORTED THE LAMITRODE HAD MULTIPLE INVALID IMPEDANCES (DEVICE 1). THE TIP OF THE OCTRODE HAD BROKEN OFF INTO THE HEADER OF THE IPG AND WAS ALSO MISSING SEVERAL ELECTRODES (DEVICE 2). IT WAS REPORTED THE SURGERY WAS EXTENDED FOR ABOUT 1.5 HOURS. IT WAS ALSO REPORTED THE PT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE WITH THE NEW SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233406 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3183 3229654

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SCS ANCHOR: MODEL 1192| IMPLANT DATE: