BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4340766 · Received December 18, 2014

    Report

    Report Number
    3007566237-2014-03672
    Event Type
    Injury
    Date Received
    December 18, 2014
    Report Date
    November 20, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    MARTÍNEZ MORENO, M., MORALEDA-PÉREZ, S., DEIANA, A., PASCUAL-PASCUAL, S. PSYCHOTIC SYMPTOMS ASSOCIATED TO INTRATHECAL BACLOFEN INFUSION. DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY. 2013. 55(44). SUMMARY/REPORTED EVENTS: A (B)(6) FEMALE PATIENT WITH BILATERAL CEREBRAL PALSY, GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM LEVEL V, TREATED WITH INTRATHECAL BACLOFEN INFUSION THROUGH AN IMPLANTABLE PUMP, WHO SUFFERED A PSYCHOTIC BREAKDOWN. AFTER 6 YEARS OF TREATMENT WITH INTRATHECAL BACLOFEN WITH GOOD RESULTS AT A DOSE OF 275 G, THE PATIENT STARTED WITH PSYCHOTIC SYMPTOMS SUCH AS PERSECUTORY DELUSIONS. OVERDOSE OF BACLOFEN WAS SUSPECTED, BUT REMOTE PUMP EVALUATION DID NOT SHOW ANY DOSAGE ERROR. CATHETER EVALUATION WITH RADIOPAQUE CONTRAST X-RAY EXAMINATION DID NOT FIND ANY CATHETER DAMAGE. THE PATIENT'S BLOOD LABORATORY DATA WERE WITHIN THE NORMAL LIMITS AND A CRANIAL COMPUTED TOMOGRAPHY SCAN SHOWED ONLY RESIDUAL LESIONS. AFTER THESE RESULTS, THE PATIENT STARTED TREATMENT WITH ARIPIPRAZOLE 10 MG, AN ANTIPSYCHOTIC DRUG, AND THE INTRATHECAL BACLOFEN DOSAGE WAS SLOWLY DECREASED, LOOKING FOR AN IMPROVEMENT OF SYMPTOMS. AS BACLOFEN DOSE WAS DECREASED THE PSYCHOTIC SYMPTOMS IMPROVED BUT SPASTICITY, ESPECIALLY IN UPPER LIMBS, SUFFERED A STEADY INCREASE NECESSITATING THE USE OF TIZANIDINE. THE PUMP WAS FINALLY REMOVED TAKING ADVANTAGE OF THE COMPLETION OF THE BATTERY. PSYCHOTIC SYMPTOMS SLOWLY DECREASED AND ANTIPSYCHOTIC MEDICATION COULD BE WITHDRAWN. THERE WAS NO EVIDENCE THAT SIDE EFFECTS WERE CAUSED BY THE INTRATHECAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832442 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Required Intervention