BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2551952 · Received April 27, 2012

    Report

    Report Number
    3007566237-2012-00919
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    September 1, 2010
    Report Date
    April 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS THE AVERAGE FOR ALL THE PATIENTS; THE MAJORITY SEX WAS NOT SPECIFIED. IMPLANTED: UNK, EXPLANTED: UNK; PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    LITERATURE: BOROWSKI, A., PRUSZCZYNSKI B., MILLER, F., SYNDER, M. "QUALITY OF LIFE IN CEREBRAL PALSY CHILDREN TREATED WITH INTRATHECAL BACLOFEN PUMP IMPLANTATION IN PARENTS' OPINION." POLISH MUSCULOSKELETAL SURGERY AND ORTHOPAEDICS 75.5 (2010): 318-322. PRINT. ABSTRACT: MOST COMMON DISORDER IN PATIENTS WITH CEREBRAL PALSY (CP) IS SPASTICITY. IT IS A RESULT OF NON-PROGRESSING DAMAGE OF UPPER MOTOR NEURON SYSTEM, CAUSING IMBALANCE SIGNALS, AND CONSEQUENTLY INCREASING MUSCLE ACTIVITY. SPASTICITY DECREASED ACTIVITY OF DAILY LIVING OF THE PATIENT AND THEIR CAREGIVERS. IT MAY CAUSE MANY MEDICAL AND SOCIAL PROBLEMS. BACLOFEN IS A SYNTHETIC ANALOG OF GAMMA-AMINOBUTRYACID, ADMINISTRATED IN INTRATHECAL SPACE BY PUMP. IT INHIBITS BOTH MONOSYNAPTICAL AND POLISYNAPTICAL SPINAL REFLEXES. FIRST TIME BACLOFEN PUMP (ITB) WERE APPLIED BY PENN AND KROIN IN 1984 TO TREAT SPASTICITY. ITB IS INDICATED IN SEVERE CHILDREN CEREBRAL PALSY, ESPECIALLY IN TETRAPARESIS. THE PURPOSE OF THIS STUDY IS ATTEMPT FOR OBJECTIVE AND SUBJECTIVE EVALUATION OF THE QUALITY OF LIFE AFTER IMPLANTATION OF ITB. IN THIS RESEARCH DATA, THE AUTHORS ANALYZE 161 CHILDREN WITH SPASTIC TETRAPARESIS (GMFCS V). EVALUATION WAS BASED ON AN ANALYSIS OF THE QUANTITY OF ADDITIONAL SURGICAL PROCEDURES BEFORE AND AFTER ITB IMPLANTATION. SUBJECTIVE ASSESSMENT WAS MADE USING QUESTIONNAIRES ADDRESSED TO PARENTS ON FUNDAMENTAL ASPECTS OF EVERYDAY ACTIVITIES AND QUALITY OF LIFE AFTER IMPLANTATION OF ITB. THE AUTHORS FIND THAT THE AVERAGE AGE AT THE TIME OF SURGERY WAS 12 YEAR AND 2 MONTHS (SD 4.7). THE AVERAGE FOLLOW UP WAS 3 YEARS AND 2 MONTHS (SD 2.4). DURING ITB IMPLANTATION, ADDITIONAL SURGICAL PROCEDURES WERE PERFORMED IN 43% OF CHILDREN. DURING THE NEXT SCHEDULED ITB, PUMP EXCHANGE INDICATION TO ADDITIONAL SURGICAL PROCEDURE WAS REDUCED TO 20%. THE AVERAGE QUESTIONNAIRE SCORE WAS 13 POINTS (0-16 MAX.). FIFTY EIGHT PERCENTS OF CAREGIVERS OF CHILDREN WHO HAD ANY KIND OF DEVICE RELATED COMPLICATION SCORED WITH AVERAGE SCORE 13.5. THE AUTHORS CONCLUDE THAT ITB IMPLANTATION IN THE TREATMENT OF CHILDREN WITH SEVERE CP IMPROVES THEIR QUALITY OF LIFE, INDICATION TO PERFORM SURGICAL PROCEDURES WERE REDUCED IN PATIENTS TREATED WITH ITB, AND ITB IMPLANTATION CORR ELATES WITH THE HIGH LEVEL OF CAREGIVERS SATISFACTION AS THE POTENTIAL FOR IMPROVEMENTS, HOWEVER, ONE HAS TO THINK ABOUT THE COMPLICATION. REPORTED EVENTS: NINETY-THREE PATIENTS (58%) EXPERIENCED COMPLICATIONS, OF WHICH 33 (20%) REQUIRED FURTHER SURGICAL TREATMENT. FIFTY-SEVEN CHILDREN (35%) EXPERIENCED COMPLICATIONS RELATED TO BACLOFEN PUMP IMPLANTATION (PUMP OR CATHETER FAILURE OR A SEVERE INFECTION) WHICH REQUIRED ADDITIONAL SURGERY. THE COMPLICATIONS AND SURGICAL TREATMENT WERE NOT SPECIFIED AND IT WAS NOT CLEAR WHICH EVENTS OCCURRED IN WHAT NUMBER OF PATIENTS IN REGARD TO THE PUMP/CATHETER FAILURE AND INFECTION. FURTHER 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
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Required Intervention PRODUCT ID NEU_UNKNOWN_CATH LOT# UNK SERIAL# UNK