BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 LEAD

    MDR report key: 1625298 · Received March 5, 2010

    Report

    Report Number
    1627487-2010-00069
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. THE LEAD PASSED FUNCTIONAL CONTINUITY AND RESISTANCE TESTING. REDDISH DISCOLORATION WAS OBSERVED AT THE LEAD SEGMENT AND PADDLE. NO OTHER VISIBLE ANOMALIES WERE NOTED. CONCLUSION: THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE LEAD WAS PLACED AT T9-T10. ON (B) (6) 2010, THE PT RETURNED TO THE HOSPITAL STATING THAT THEY HAD "NO POWER OF FEELING IN EITHER LOWER EXTREMITY." IT WAS REPORTED THE NEUROLOGY CONSULT WAS NORMAL, REFLEX TEST WAS NORMAL, AND CT WAS NORMAL. PT DEMANDED A FULL EXPLANT OF THE SYSTEM THAT WAS PERFORMED ON (B) (6) 2010. ON 02/10/ 2010, IT WAS REPORTED THE RESULTS OF THE MRI (PERFORMED ON (B) (6) 2010) REVEALED BLOOD IN THE EPIDURAL SPACE AT T8/7 ABOVE THE LEVEL OF THE PADDLE PLACEMENT. IT WAS REPORTED THE PHYSICIAN STATED THEY DID NOT BELIEVE THERE WAS ENOUGH BLOOD TO PLACE PRESSURE ON THE CORD. THE PHYSICIAN PERFORMED A LAMINECTOMY AND CLEARED OUT THE BLOOD. THE PHYSICIAN ALLEGED THE LEAD STIFFNESS MAY HAVE PLAYED A PART IN THE POSSIBILITY OF HITTING AN EPIDURAL VEIN DURING PADDLE PLACEMENT. THE PT HAS REGAINED FEELING AND POWER IN THEIR LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3244 280863

    Patients

    Seq Age Sex Outcome Treatment
    1 Other