BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3900122 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-02363
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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

    THE PATIENT RECEIVED TWO SCS LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING UNCOMFORTABLE STIMULATION AND WOULD LIKE TO HAVE HER SCS SYSTEM EXPLANTED BECAUSE THE SYSTEM IS NOT HELPING HER PAIN. FOLLOW UP ON (B)(6) 2014 IDENTIFIED A SJM REPRESENTATIVE MET WITH THE PATIENT. THE PATIENT REPORTED, SHE CONTINUED TO EXPERIENCE UNCOMFORTABLE AND INEFFECTIVE STIMULATION. A SYSTEM DIAGNOSTICS REVEALED ONE OF THE PATIENT'S LEADS HAS MULTIPLE INVALID CONTACTS. IN ADDITION, X-RAYS TAKEN DID NOT SHOW ANY FRACTURES; HOWEVER, A SHARP BEND NEAR THE ANCHOR WAS OBSERVED. THE REPRESENTATIVE REPROGRAMMED THAT PATIENT'S SCS SYSTEM USING ONLY ONE LEAD. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315172 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3186 3883578

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SCS LEAD: MODEL 1192 (X2),| IMPLANT DATE:| SCS IPG: MODEL 3788,| IMPLANT DATE: