BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2251294 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-04187
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 2 OF 2. REFERENCE: 1627487-2011-04186. THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010, INCLUDING TWO LEADS WITH DIFFERENT LOT NUMBERS. IT WAS REPORTED THE PATIENT EXPERIENCES A SHOCKING SENSATION IN HER RIGHT ARM, WHETHER STIMULATION IS ON OR OFF. THE PATIENT'S SCS SYSTEM WAS REPROGRAMMED TO STIMULATE THIS AREA. REPROGRAMMING WAS TRIED, BUT THIS DID NOT ALLEVIATE THE SYMPTOM. AN X-RAY WAS PERFORMED. THE LEAD HAD MIGRATED SLIGHTLY, THE PATIENT WAS REPROGRAMMED ONLY USING ONE LEAD, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3097022

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788