BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3682502 · Received January 13, 2014

    Report

    Report Number
    1627487-2014-23064
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 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 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 1 OF 2. REF MFR REPORT #161487-2014-23065. THE PT HAS 3 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PT HAS NOT USED HIS SCS SYSTEM IN YEARS. IT WAS ALSO REPORTED THE SYSTEM DID NOT ALLEVIATE THE PT'S PAIN; AS A RESULT, HE TURNED THE STIMULATION OFF AND DISCONTINUED USE. THE SJM REP SUGGESTED REPROGRAMMING TO THE PT; HOWEVER, HE DECLINED. THE PT REPORTED A DESIRE TO HAVE THE SYSTEM EXPLANTED. THE SJM REP HAS ATTEMPTED TO CONTACT THE PT REGARDING SURGICAL INTERVENTION; HOWEVER, TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25833 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3141 69138

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SCS LEAD: MODEL 3263| SCS IPG: MODEL 3688| SCS EXTENSION: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE: