BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052373 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-15449
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    March 14, 2013
    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 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 # 1627487-2013-15448. THE PT HAS 3 LEADS (ONE FROM ONE LOT AND TWO FROM A DIFFERENT LOT) IMPLANTED. IT WAS REPORTED, THAT PT EXPERIENCES INEFFECTIVE STIMULATION. THE PT INDICATES HE FEELS STIMULATION IN HIS PHANTOM LIMB, BUT THE STIMULATION IS STRONGER IN HIS BUTTOCKS RATHER THAN IN HIS FOOT. THE PT UNDERWENT A TRIAL PROCEDURE TO ADDRESS THIS ISSUE. DECENT COVERAGE OF THE PT'S PAIN PATTERN WAS ACHIEVED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137437 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3315453

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: