BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3162411 · Received June 6, 2013

    Report

    Report Number
    1627487-2013-04729
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 16, 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 3 OF 3. REFERENCE MFR REPORT: 1627487-2013-04727, 04728. IT WAS REPORTED THE PATIENT RECEIVED A PAIN PUMP AND QUIT USING THE SCS SYSTEM AND QUIT RECHARGING THE IPG. THE SJM REPRESENTATIVE DETERMINED THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. THE PATIENT REPORTED HE ATTEMPTED USING THE PAIN PUMP AND THE STIMULATION AT THE SAME TIME ONE YEAR AGO, BUT THE STIMULATION WAS NOT PROVIDING EFFECTIVE COVERAGE IN HIS BACK AND HE QUIT USING THE SYSTEM. THE PATIENT REPORTED AT ONE TIME HE DID RECEIVE STIMULATION COVERAGE, BUT REPROGRAMMING WAS UNABLE TO RECAPTURE THE STIMULATION. THE PATIENT STATED HE DID NOT WANT TO PURSUE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251690 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2787308

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE: