BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2973679 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-13314
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    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 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-13315. IT WAS REPORTED THE PATIENT WASN'T RECEIVING EFFECTIVE STIMULATION. A SJM REPRESENTATIVE RAN A FULL LEAD DIAGNOSTIC; 4 OF THE CONTACTS HAD LOW IMPEDANCES. THE REPRESENTATIVE WAS ABLE TO REPROGRAM AROUND THE CONTACTS AND CAPTURE SOME STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72708 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3315453

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1192 (2)