BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3102032 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-03603
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    March 17, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 3 OF 3. REF MFR REPORTS: 1627487-2013-03601 AND 1627487-2013-03602. THE PT HAS 3 OCCIPITAL (OFF-LABEL) SCS LEADS WITH DIFFERENT LOT NUMBERS. THE PT REPORTED SHE IS NO LONGER RECEIVING EFFECTIVE STIMULATION DUE TO THE INABILITY TO INCREASE STIMULATION TO AN ADEQUATE AMPLITUDE. F/U IDENTIFIED LEAD DIAGNOSTICS SHOWED INVALID IMPEDANCE VALUES FOR THE PT'S LEFT OCCIPITAL SCS LEAD; HOWEVER, THE SJM REP WAS ABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. ON (B)(6) 2013 F/U IDENTIFIED THE PT'S SCS LEADS WERE REPLACED AND THE PT IS RECEIVING EFFECTIVE STIMULATION. ADDITIONALLY, THE PT'S SCS IPG WAS REPLACED (REF MFR REPORT: 1627487-2013-03605).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197039 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 173789

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS EXTENSION: MODEL 3386 (2)