BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3241009 · Received July 18, 2013

    Report

    Report Number
    1627487-2013-11049
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 #: 1627487-2013-11048. THE PATIENT HAS THREE LEADS (TWO ARE FROM THE SAME LOT). IT WAS REPORTED, THE PATIENT IS UNABLE TO RECEIVE ADEQUATE COVERAGE. IT WAS ALSO REPORTED, THE PATIENT'S PROGRAMS WERE AUTO REDUCING. AS A RESULT, AN SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING. AN IMPEDANCE CHECK REVEALED SEVERAL INVALID CONTACTS. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT WILL MOVE FORWARD WITH SURGICAL INTERVENTION IF HE FEELS THE NEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335234 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3346017

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR IMPLANT:| IMPLANT:| SCS IPG: MODEL 3716| SCS EXTENSIONS: MODEL: 3382 (X2)