BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 8

    MDR report key: 3821167 · Received May 9, 2014

    Report

    Report Number
    1627487-2014-03330
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 18, 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 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. REFERENCE MFR. REPORT: 1627487-2014-03329. IT WAS REPORTED THE PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION IN HIS PAIN PATTERN AND IS NOT RECEIVING ANY STIMULATION AT THE TOP OF HIS HEAD FOLLOWING AN ELECTIVE SCS IPG EXPLANT/REPLACEMENT PROCEDURE ON (B)(6) 2014. SUBSEQUENTLY, ON (B)(6) /2014, THE PT UNDERWENT EXPLORATORY SURGERY DURING WHICH THE SCS IPG POCKET SITE WAS OPENED, THE OCCIPITAL SCS LEADS (OFF-LABEL) DISCONNECTED FROM THE SCS IPG AND WIPED THEN RECONNECTED AND TESTED. ALTHOUGH, THE IMPEDANCE VALUES WERE LOWER DURING THIS TEST, THEY WERE STILL WITHIN NORMAL LIMITS. THE PT'S STIMULATION WAS THEN TURNED ON WITH STIMULATION BEING FELT IN THE PT'S PAIN PATTERN WITH THE EXCEPTION OF THE TOP OF HIS HEAD. THE PHYSICIAN DECIDED TO NOT PURSUE INTERVENTION AT THIS TIME OF THE PROCEDURE. FOLLOW-UP IDENTIFIED AS OF (B)(6) 2014, THE PT IS STILL EXPERIENCING LOSS OF STIMULATION AT THE TOP OF HIS HEAD (EFFECTIVE STIMULATION IS REMAINING PAIN PATTERN). SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE BY ADDING AN ADDITIONAL SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281136 LAMITRODE 8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3280 3253465

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other SCS EXTENSION: MODEL 3383 (2)| SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1194 (2)| IMPLANTED: