BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2821651 · Received November 6, 2012

    Report

    Report Number
    3007566237-2012-02635
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    August 3, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TURNER, M., NGUYEN, H. S., COHEN-GADOL, A. A. INTRAVENTRICULAR BACLOFEN AS AN ALTERNATIVE TO INTRATHECAL BACLOFEN FOR INTRACTABLE SPASTICITY OR DYSTONIA: OUTCOMES AND TECHNICAL CONSIDERATIONS. JOURNAL OF NEUROSURGERY: PEDIATRICS. 2012;10(4):315-319. DOI: 10.3171/2 012.6.PEDS11456. SUMMARY: THE AIM OF THIS STUDY WAS TO IDENTIFY THE BENEFITS OF INTRAVENTRICULAR BACLOFEN (IVB) THERAPY FOR THE TREATMENT OF INTRACTABLE SPASTICITY OR DYSTONIA IN A SUBSET OF PATIENTS WHO HAD EXPERIENCED MULTIPLE REVISIONS WHILE RECEIVING INTRATHECAL BACLOFEN (ITB) THERAPY. THE AUTHORS REVIEWED THE CHARTS OF 22 CONSECUTIVE PATIENTS WITH INTRACTABLE SPASTICITY OR DYSTONIA WHO INITIALLY UNDERWENT ITB THERAPY, SUBSEQUENTLY SUFFERED MULTIPLE REVISIONS DURING ITB THERAPY, AND ULTIMATELY RECEIVED IVB THERAPY, ALL DURING A 12-YEAR PERIOD FROM (B)(6) 1998 TO (B)(6) 2010. THE INTRAVENTRICULAR CATHETERS WERE POSITIONED IN THE LATERAL VENTRICLE, AIDED BY STEREONAVIGATION. THE SURGICAL REVISION RATE (THE AVERAGE NUMBER OF SURGICAL REVISIONS PER AVERAGE NUMBER OF FOLLOW-UP YEARS) DURING ITB THERAPY WAS 0.84, AND WAS 0.50 DURING IVB THERAPY. THE MOST FREQUENT COMPLICATION REQUIRING SURGICAL REVISION DURING ITB THERAPY WAS CATHETER OCCLUSION, FOLLOWED BY PUMP MALFUNCTION/PUMP POCKET ISSUES, AND INFECTION. THE MOST FREQUENT COMPLICATION REQUIRING SURGICAL REVISION DURING IVB THERAPY WAS INFECTION, FOLLOWED BY CATHETER MISPLACEMENT/MIGRATION. FOUR PATIENTS SUFFERED INFECTION THAT REQUIRED REMOVAL OF THEIR INTRAVENTRICULAR CATHETER, AND CURRENTLY HAVE NO BACLOFEN SYSTEM. SOME OF THESE PATIENTS HAD A HISTORY OF INCREASING REVISIONS WITH INCREASING FREQUENCY DURING ITB THERAPY. SUCH A HISTORY PUTS THEM AT RISK FOR SPINAL ARACHNOIDITIS, A CONDITION THAT COMPLICATES FURTHER ITB THERAPY. FOR SUCH PATIENTS, THE AUTHORS BELIEVE THAT IVB THERAPY MAY BE A BENEFICIAL THERAPEUTIC OPTION, GIVEN THAT THE SURGICAL REVISION RATE WAS LOWER FOR IVB THAN FOR ITB. INTRAVENTRICULAR BACLOFEN MAY BE A COST-EFFECTIVE OPTION FOR PATIENTS WITH MOUNTING REVISIONS DURING ITB THERAPY. REPORTED EVENT: PATIENT (B)(6): 3 REVISIONS OCCURRED DURING ITB THERAPY AND 2 OCCURRED DURING IVB THERAPY. IT WAS NOTED THAT THE PATIENT HAD A CONCOMITANT VENTRICULOPERITONEAL SHUNT. IT WAS NOT POSSIBLE TO TELL HOW MANY REVISIONS WERE RELATED TO THE PUMP VS CATHETER OR HOW MANY PUMPS AND CATHETERS THE PATIENT HAD REPLACED IN THE PERIOD OF TIME. 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
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention