BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3850313 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-26419
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 23, 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: 1627487-2014-26401. THE PT RECEIVED A SCS SYSTEM WHICH INCLUDED TWO LEAD EXTENSIONS FROM DIFFERENT LOTS. IT WAS REPORTED THE PT EXPERIENCED A SIGNIFICANT INCREASE IN STIMULATION ON HIS RIGHT SIDE (MOSTLY IN HIS ARM) AFTER HE HAD LEANED OVER AND RETURNED TO A STANDING POSITION. DIAGNOSTIC TESTING IDENTIFIED INVALID IMPEDANCES. REPROGRAMMING PROVED TO BE UNSUCCESSFUL WITH ONLY SHORT-TERM RELIEF TO THE NEEDED AREAS AND AN INCREASE OF UNWANTED STIMULATION TO THE PT'S RIGHT ARM. THE PHYSICIAN ELECTED TO PROCEEDED WITH SURGICAL INTERVENTION. INTRAOPERATIVE TESTING DETERMINED THE ISSUE WAS WITH THE LEAD EXTENSIONS. THE LEAD EXTENSIONS WERE EXPLANTED AND REPLACED WHICH RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290599 SINGLE EXTENSION SCS EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3383 3756979

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other IMPLANTED:| SCS LEAD: MODEL 3228| SCS IPG: MODEL 3788| IMPLANTED: