BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2962081 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00487
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: UNK, SERIAL/LOT#: UNK, IMPLANTED: UNK, EXPLANTED: UNK. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    BEAUFILS J, FERRAPIE AL, DINOMAIS M, SAOUT V, MENEI P, RICHARD I. PROGRESSION OF SCOLIOSIS AFTER INTRATHECAL BACLOFEN IN AN ADULT PATIENT WITH MULTIPLE SCLEROSIS. ANNALS OF PHYSICAL AND REHABILITATION MEDICINE. 2012;55 (SUPPL 1): E206-E207+E208. SUMMARY/REPORTED EVENT: INTRATHECAL BACLOFEN (ITB) INDUCES MODIFICATION OF AXIAL TONUS. THE ROLE OF ITB IN THE EVOLUTION OF SCOLIOSIS HAS BEEN STUDIEDMAINLY IN CEREBRAL PALSY. WE PRESENT THE CASE REPORT OF AN ADULT FEMALE MULTIPLE SCLEROSIS PATIENT WHO DEVELOPED A MAJOR SCOLIOSIS AFTER IMPLANTATION OF A BACLOFEN PUMP. CASE REPORT.- A WOMAN, 45 YEARS OLD, WITH SPASTIC QUADRIPLEGIA SECONDARY TO MULTIPLE SCLEROSIS EVOLVING SINCE 1984 PRESENTS THORACOLUMBAR PAIN 30 MONTHS AFTER INTRATHECAL BACLOFEN PUMP INSERTION IN 2006 AT THE AGE OF 40. PLAIN X-RAYS SHOW A RAPIDLY PROGRESSING RIGHT THORACOLUMBAR SCOLIOTIC CURVE (COBB ANGLE OCTOBER 15, 2008: 78 VERSUS 548 ON JANUARY 12, 2012) REQUIRING A T3-SACRUM POSTERIOR FUSION FEBRUARY 1, 2012). THIS PATIENT HAS NO HISTORY OF IDIOPATHIC SCOLIOSIS AND HAD NOT REPORTED BACK PAIN PRIOR TO IMPLANTATION. DISCUSSION.- SEVERAL STUDIES REPORT THE EVOLUTION OF SCOLIOSIS AFTER BIT IN CEREBRAL PALSY AND DISCUSS THE ROLE OF THE TREATMENT VERSUS THE EVOLUTION DUE TO SKELETAL MATURATION [1,2]. OUR CASE REPORT HIGHLIGHTS THAT MAJOR AGGRAVATION OF SCOLIOSIS MAY OCCUR AFTER ITB, IN ADULTS OUTSIDE THE RISK PERIODS OF ADOLESCENCE AND MENOPAUSE. THIS DRAWS OUR ATTENTION TO THE NECESSITY OF REGULAR FOLLOW UP OF THE SPINE AFTER ITB. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65765 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Other| S