BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3231401 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-00392
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 17, 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
    GM
    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

    IT WAS REPORTED THE PT (B)(6) SUDDENLY LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS. AN X-RAY WAS ALSO TAKEN FOR FURTHER INTERROGATION; HOWEVER, THE RESULTS WERE NOT DISCLOSED. THE PT DENIES ANY TRAUMATIC EVENTS WHICH MAY HAVE ATTRIBUTED TO THIS OCCURRENCE. SURGICAL INTERVENTION WAS UNDERTAKEN TO ADDRESS THIS MATTER. THE PT'S ENTIRE THERAPY SYSTEM WAS EXPLANTED AT THIS REQUEST DUE TO LACK OF EFFICACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322357 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3654474

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other SCS ANCHOR: MODEL 1192| IMPLANT DATE: