BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4031560 · Received August 22, 2014

    Report

    Report Number
    3007566237-2014-02356
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DROWSINESS THAT HAD NOT RECOVERED. ON (B)(6) A REFILL WAS PERFORMED AND THE EFFECTS BEGAN TO APPEAR. SINCE THE ANTI-SPASTICITY/SPASMOGENIC EFFECTS WERE TOO STRONG, THE DOSAGE WAS REDUCED BY 20% (FROM 435 ¿G TO 362 ¿G). ON (B)(6), A VISIT TO THE HOSPITAL NOTED THE PATIENT OFTEN SEEMED TO BE IN A DAZE AND DIZZY IN DAYTIME SO THE DOSAGE WAS AGAIN REDUCED BY 20% (NOW FROM 362 ¿G TO 300 ¿G). ON (B)(4), THE DOSE WAS AGAIN REDUCED BY 20% (FROM 300 ¿G TO 235 ¿G) BY USING THE FLEX MODE DURING DAYTIME. ON (B)(4), THE DOSAGE WAS REDUCED BY 20% AGAIN (FROM 235 ¿G TO 185 ¿G) DUE TO DROWSINESS AND BEING SLEEPY IN THE DAYTIME. IT WAS DIFFICULT TO IDENTIFY A CAUSE SINCE THE DOSAGE INCONSISTENCY BETWEEN DAY AND NIGHT TIMES AND THEREFORE IT WAS DECIDED TO RETURN TO THE SIMPLE CONTINUOUS MODE AND CONTINUE IN REDUCING THE DOSAGE. NO TESTING WAS PERFORMED. THIS WAS REPORTED TO BE VERY LIKELY RELATED TO THE INVESTIGATIONAL DRUG, INTRATHECAL GABALON AND NOT RELATED TO THE CATHETER, PUMP, PROGRAMMER OR PROCEDURE. GOING FORWARD IT WAS TO BE CONFIRMED WHETHER OR NOT THE SITUATION WAS ALLEVIATED BY DOSAGE REDUCTION AND WHETHER THE SITUATION WAS INDEED DUE TO GABALON INTRATHECAL OR ANOTHER REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509256 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R