BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPOLE 16C LAMITRODE LEAD

    MDR report key: 1011425 · Received March 11, 2008

    Report

    Report Number
    1627487-2008-00001
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. NO ANOMALIES WERE FOUND. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN SCS IPG AND LEAD IN 2008. IT WAS REPORTED THAT APPROX 45 MINUTES POST-OPERATIVELY, THE PT WAS UNABLE TO FEEL HER LEFT LEG. THE PT WAS TAKEN BACK TO THE OR WHERE THE LEAD WAS REMOVED. THE EXPLANTED LEAD WAS NOT RETURNED TO ANS FOR EVALUATION. IT WAS REPORTED FOUR DAYS LATER, THAT THIS PT WAS PARALYZED IN BOTH LEGS FROM THE WAIST DOWN AND HAD LOSS OF BLADDER AND BOWEL FUNCTION. FOLLOW-UP ON THE PT FOUND THAT HER IPG WAS EXPLANTED TWO DAYS LATER, AND SHE IS CURRENTLY AT A REHABILITATION HOSPITAL WITH NO CHANGE IN HER CONDITION. A USER FACILITY REPORT WAS SENT TO ANS THE FOLLOWING MONTH, AND DESCRIBES THAT DURING LEAD INSERTION THE LEAD "WAS SLIGHTLY RIGHT OF MIDLINE. ATTEMPT TO MOVE LEFT BUT WANTED TO GO RIGHT. SURGEONS OKAYED SITE." AN MRI DONE AFTER LEAD EXPLANATION "SHOWED COD HEMORRHAGE AND SOME MILD ENHANCEMENT COMPATABLE WITH TRAUMATIC INJURY WITHIN THE CORD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 16C LAMITRODE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3214 97391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other