BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3113273 · Received April 25, 2013

    Report

    Report Number
    1627487-2013-05589
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 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 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#: 1627487-2013-05590. IT WAS REPORTED THE PT EXPERIENCED AUTO REDUCING WHEN STIMULATION WAS ACTIVATED. AN IMPEDANCE CHECK REVEALED INVALID CONTACTS ON ONE OF THE PT'S LEADS. REPROGRAMMING WAS UNSUCCESSFUL. AS A RESULT, THE PT MAY UNDERGO X-RAYS AND SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180440 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3744686

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANT:| SCS IPG: MODEL: 3788