BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2802956 · Received October 19, 2012

    Report

    Report Number
    1627487-2012-06599
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    March 25, 2012
    Report Date
    September 25, 2012
    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 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. REFERENCE MFR. REPORT #: 1627487-2012-06600. IT WAS REPORTED THE PT LOST STIMULATION. AN IMPEDANCE CHECK REVEALED INVALID CONTACTS. THE PT PLANS TO HAVE THE SCS SYSTEM EXPLANTED ON A LATER DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANT:| SCS ANCHORS: MODEL 1192(2)| IMPALNT:| SCS IPG: MODEL 3788