BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2992291 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-03307
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03306. THE PATIENT RECEIVED 2 SCS LEADS WITH DIFFERENT LOT NUMBERS. IT WAS REPORTED, THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION. IT WAS ALSO REPORTED THE PATIENT EXPERIENCES OVERSTIMULATION AND A SHOCKING SENSATION WHEN USING SYSTEM STIMULATION. SUBSEQUENTLY, THE PATIENT HAS BEEN TO THE ER MULTIPLE TIMES. FOLLOW-UP IDENTIFIED A SJM REPRESENTATIVE WAS ABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89511 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 39276

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3716