BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2971451 · Received February 4, 2013

    Report

    Report Number
    1627487-2013-04132
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 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 INFO 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: 1627487-2013-04131. IT WAS REPORTED THE PT FELT A CHANGE IN HER STIMULATION. AN X-RAY REVEALED THE LEAD HAD MIGRATED HIGHER IN POSITION. REPROGRAMMING WAS UNABLE TO PROVIDE STIMULATION COVERAGE. IT WAS REPORTED THE PT WAS SCHEDULED FOR A KNEE SURGERY, AND WOULD RETURN FOR ADD'L REPROGRAMMING AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47534 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3186 3799210

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788