BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3222936 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-04860
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 17, 2013
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-04861. IT WAS REPORTED THE PATIENT HAD PERFORMED PHYSICAL ACTIVITY AND LOST STIMULATION COVERAGE IN THE BACK AREA, BUT STILL HAD COVERAGE IN THE LEGS. X-RAYS DID NOT REVEAL ANY ANOMALIES. INITIALLY, REPROGRAMMING WAS ABLE TO PROVIDE STIMULATION COVERAGE. FOLLOW UP IDENTIFIED THE PHYSICIAN HAD EXPLANTED THE SCS SYSTEM BECAUSE THE PATIENT NO LONGER HAD EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315113 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3183 3250358

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT: