BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2894826 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-02875
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2012-02876. IT WAS REPORTED THE PT'S PROGRAMS FOR HER SCS SYSTEM HAD STOPPED WORKING. DIAGNOSTIC TESTS EXHIBITED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACT. REPROGRAMMING WAS UNSUCCESSFUL AT PROVIDING EFFECTIVE STIMULATION COVERAGE. IT WAS REPORTED MAXIMUM POWER OUTPUT WAS REACHED AT AN AMPLITUDE OF 9 MA, AT WHICH POINT THE PT COULD NOT FEEL STIMULATION. X-RAYS REVEALED NO LEAD FRACTURE. F/U IDENTIFIED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3486458

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788