BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2921937 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-15027
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 23, 2010
    Report Date
    December 12, 2012
    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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REF MFR REPORT: 1627487-2013-15026. THE PT HAD TWO LEADS FROM DIFFERENT LOTS IMPLANTED. IT WAS REPORTED THE PT WAS NOT RECEIVING ADEQUATE STIMULATION. F/U IDENTIFIED THE PHYSICIAN REPLACED BOTH LEADS WITH ONE SURGICAL LEAD. IT WAS REPORTED THE PT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5422 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3153779

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: