BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2831678 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-06732
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 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

    RESULTS - THE KINK OBSERVED ON THE LEAD AS INDICATED IN THE EVENT DETAILS WAS DUE TO THE KINK ON THE STYLET. THE DAMAGE WAS CONSISTENT WITH AN OVERSTRESS CONDITION THE LEAD WAS SUBJECTED TO DURING THE IMPLANT PROCEDURE. 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

    THE PT HAD TWO LEADS (FROM THE SAME LOT). DURING A TRIAL PROCEDURE, ONE OF THE LEADS WAS DAMAGED WHEN THE DOCTOR ATTEMPTED TO REMOVE THE STYLET. THE DAMAGED LEAD WAS REMOVED. IT WAS ALSO REPORTED THE PT EXPERIENCED RIB STIMULATION WHILE IN RECOVERY. X-RAYS REVEALED THE REMAINING LEAD HAD MIGRATED. AS A RESULT, THE REMAINING LEAD WAS REMOVED AND WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3786313

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention