BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3022407 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-03409
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 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
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-03410. IT WAS REPORTED DURING A LEAD REVISION PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE SCS LEAD DUE TO SCAR TISSUE. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO ABANDON THE PROCEDURE. THE PATIENT'S SCS IPG WAS LEFT IMPLANTED. IT WAS ALSO REPORTED DURING THE PROCEDURE, THE PHYSICIAN "NICKED" THE PATIENT'S SPINAL CORD. SUBSEQUENTLY, THE PATIENT POST-OPERATIVELY EXPERIENCED PAIN AND WEAKNESS IN HER LOWER EXTREMITIES AND WAS SENT TO THE EMERGENCY ROOM FOR TESTS AND IMAGING. FOLLOW-UP IDENTIFIED IMAGING CONFIRMED A CSF LEAK. ADDITIONALLY, THE PATIENT HAS MADE A FULL RECOVERY AND THE ISSUE HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120985 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3853534

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788