BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, DUAL 4 CHANNEL 60CM

    MDR report key: 2050934 · Received April 4, 2011

    Report

    Report Number
    1627487-2011-00455
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATION AND NO ANOMALIES WERE FOUND. AS RECEIVED, THE LEAD SEGMENT OF THE EXTENSION WAS SEVERELY KINKED WITH ALL WIRES BROKEN AT APPROXIMATELY 11CM FROM THE HEADER END. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 RECEIVED AN SCS SYSTEM INCLUDING FOUR PERCUTANEOUS LEADS IMPLANTED IN THE SUPRAORBITAL AREA (OFF-LABEL LOCATION) AND A LEAD EXTENSION ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING STIMULATION FROM THE LEADS. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS, AND AN X-RAY SHOWED THE EXTENSION TO BE SEATED IN THE HEADER. SURGICAL INTERVENTION WAS UNDERTAKEN TO RECTIFY THIS MATTER. NO IMPEDANCE ISSUES WERE FOUND WITH THE LEADS DURING INTRAOPERATIVE TESTING. AS SUCH, THE PHYSICIAN REPLACED THE PATIENT'S EXTENSION. EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, DUAL 4 CHANNEL 60CM SPINAL CORD STIMULATION EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3346 2894247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention