BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2852314 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-00776
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 7, 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 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

    THE PATIENT WAS IMPLANTED WITH TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT FELL DOWN THE STAIRS AND AFTER WHICH HER STIMULATION CHANGED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PATIENT'S LEADS AND EFFECTIVE STIMULATION WAS RECAPTURED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3290702

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL: 1194 (2)