BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3940484 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-02437
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS
    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 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: 1627487-2014-02436. IT WAS REPORTED THE PATIENT IS NOT FEELING AN STIMULATION FROM HER SCS SYSTEM. THE PATIENT STATED THAT APPROXIMATELY THREE MONTHS AGO, HER STIMULATION CHANGED. ON (B)(6) 2014, THE PATIENT REPORTED SHE STOPPED FEELING THE STIMULATION. A SJM REPRESENTATIVE MET WITH THE PATIENT AND ATTEMPTED TO REPROGRAM THE PATIENT'S SYSTEM, BUT WAS NOT SUCCESSFUL. INVALID IMPEDANCES WERE OBSERVED DURING THE REPROGRAMMING ATTEMPTS. IN ADDITION, THE PATIENT STATED SHE EXPERIENCED A FALL APPROXIMATELY A YEAR AGO, HOWEVER, THERE WAS NO CHANGE IN SCS SYSTEM PERFORMANCE. THE PHYSICIAN HAS ORDER X-RAYS TO FURTHER EVALUATE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357771 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS 3186 3250300

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192(X2)