BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2930552 · Received January 24, 2013

    Report

    Report Number
    1627487-2013-13110
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    June 1, 2012
    Report Date
    January 4, 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 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. REF MFR REPORT: 1627487-2013-13109. THE PT HAD ONE SURGICAL LEAD AND ONE PERCUTANEOUS LEAD, REPORTING ON BOTH LEADS. THE PT REPORTED HE HAD A FALL LAST SUMMER. THE PT STATED HIS SCS SYSTEM HAD NOT BEEN WORKING PROPERLY SINCE THE FALL. THE PT ALSO STATED HIS NECK HAD SWOLLEN TO WHAT HE DESCRIBED AS THE SIZE OF A GOLF BALL AT THE LEAD SITE. THE PT FELT STIMULATION ACROSS HIS BACK, UNDER HIS ARM PITS, AND DOWN BOTH ARMS TO HIS FINGERS WHILE HIS STIMULATION WAS TURNED OFF. THE PT STATED IT CAUSED HIS HANDS TO BECOME NUMB. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33653 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3181 171866

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention SCS IPG, MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION, MODEL 3386 (2)