BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 1910881 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03373
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 RECEIVED HER SCS SYSTEM INCLUDING A SURGICAL LEAD FOR PAIN IN HER LEFT LEG ON (B)(6) 2010. AN X-RAY TAKEN AFTER THE PROCEDURE CONFIRMED THE LEAD WAS ANCHORED IN THE DESIRED POSITION; HOWEVER, BECAUSE THE PATIENT WAS UNDER GENERAL ANESTHESIA, NO INTRAOPERATIVE PROGRAMMING WAS PERFORMED. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT WAS ONLY RECEIVING STIMULATION IN HER RIGHT LEG. A SECOND X-RAY WAS TAKEN WHICH VERIFIED THE LEAD HAD POSSIBLY MIGRATED FROM THE ORIGINAL IMPLANT POSITION. A FEW DAYS LATER, THE PHYSICIAN SURGICALLY REPOSITIONED AND ANCHORED THE LEAD. POST-OPERATIVE PROGRAMMING WAS PERFORMED AND THE PATIENT CONFIRMED SHE WAS RECEIVING STIMULATION IN HER LEFT LEG. IT WAS REPORTED THAT A FEW DAYS LATER, THE PATIENT WAS AGAIN RECEIVING STIMULATION IN HER RIGHT LEG ONLY. THE PHYSICIAN TOOK X-RAYS WHICH CONFIRMED PROPER POSITION OF THE LEAD. REPROGRAMMING WAS DONE TO ATTEMPT TO REGAIN COVERAGE IN THE PATIENT'S LEFT LEG. FOLLOW UP ON THE PATIENT FOUND THAT SHE IS STILL NOT RECEIVING COVERAGE IN THE DESIRED LEFT LEG AREA. THE PATIENT WILL BE RETURNING TO THE PHYSICIAN'S OFFICE FOR FUTURE REPROGRAMMING APPOINTMENTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO DEVICES WERE EXPLANTED AND NONE WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3170310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention