BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2955025 · Received February 11, 2013

    Report

    Report Number
    3007566237-2013-00445
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    NAJARIAN, C. R., TANIGUCHI, M., KRACH, L. E., STANSBURY, J., BONAU, T., PARTINGTON, M. CATHETER ACCESS PORT ASPIRATION TO ASSESS INTRATHECAL BACLOFEN WITHDRAWAL. DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY. 2012;MED(-):3-4. DOI: 10.1111/J.1469-8749.2012.04387.X. SUMMARY: THE AIM OF THE STUDY WAS TO DESCRIBE THE INSTITUTION'S EXPERIENCE WITH INTRATHECAL BACLOFEN WITHDRAWAL, SPECIFICALLY WITH EVALUATING CATHETER ASPIRATIONS. A TOTAL OF 127 ASPIRATIONS WERE REVIEWED. 75% WERE DONE FOR WORKUP OF WITHDRAWAL SYMPTOMS THAT ALSO LED TO FURTHER TREATMENT. SUCCESS WAS EVALUATED SEPARATELY FROM MEDICAL TREATMENT VS. SURGICAL TREATMENT. TYPES OF INTERVENTIONS PERFORMED WERE BASED OFF OF SUCCESS OF CATHETER ACCESS PORT ASPIRATIONS. REPORTED EVENT: OF THE 127 ASPIRATIONS REVIEWED, 95/127 OF THEM WERE DONE FOR WORKUP OF WITHDRAWAL SYMPTOMS THAT ALSO LEAD TO FURTHER TREATMENT. FREQUENCY OF SYMPTOMS INCLUDED ITCHING (24.8%), INCREASED TONE (75.3%), INCREASED DOSE WITHOUT THERAPEUTIC EFFECT (16.8%), HYPERTHERMIA (1.0%), INCREASED CPK (1.0%), HALLUCINATIONS (3.0%), INVOLUNTARY MOVEMENTS (18.8%), AND DIAPHORESIS (5.9%). OF THOSE ASPIRATIONS THAT LED TO MEDICAL TREATMENT, 61.3% HAD SYMPTOMS RESOLVE AND 38.7% HAD SYMPTOMS PERSIST. OF THOSE ASPIRATIONS THAT LED TO SURGICAL TREATMENT, 69.7% HAD SYMPTOMS RESOLVE AND 30.3% HAD THEM PERSIST. IT WAS NOT POSSIBLE TO ASCERTAIN HOW MANY PATIENTS EXPERIENCED EACH SYMPTOM, OR MORE THAN ONE SYMPTOM, OR HOW MANY DEVICES HAD ASPIRATION ISSUES AND AN UNDERLYING CATHETER ISSUE. 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
    58163 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention