BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5286843 · Received December 10, 2015

    Report

    Report Number
    3004209178-2015-24854
    Event Type
    Injury
    Date Received
    December 10, 2015
    Date of Event
    November 17, 2015
    Report Date
    November 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) VIA THE MANUFACTURING REPRESENTATIVE, REGARDING A (B)(6) MALE PATIENT RECEIVING INTRATHECAL GABLOFEN 2000MCG/ML AT 1591MCG/DAY VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE OF THE DEVICE WAS FOR INTRACTABLE SPASTICITY AND HEAD/BRAIN INJURY. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HISTORY WAS REPORTED AS ANOXIC BRAIN INJURY. IT WAS REPORTED THAT WITH INCREASED DOSE THE PATIENT HAD BEEN EXPERIENCING SYMPTOMS OF PERIODIC STARING WITH DECREASED RESPONSIVENESS. WITH MOST RECENT INCREASE TO 1591 MCG/DAY OF INTRATHECAL GABLOFEN, THESE EPISODES INCREASED AND WERE ACCOMPANIED BY HIGH BLOOD PRESSURE AND TREMORS. IT WAS THOUGHT/SUSPECTED THE PATIENT WAS HAVING FOCAL SEIZURES. A DYE STUDY WAS RECOMMENDED. THE ISSUE WAS NOT RESOLVED. ADDITIONAL INFORMATION WOULD BE OBTAINED FROM THE HCP ON (B)(6) 2015. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS "ALIVE- NO INJURY." NO SURGICAL INTERVENTION WAS PLANNED OR HAS OCCURRED. ADDITIONAL INFORMATION RECEIVED FROM THE HCP (NEUROLOGIST) REPORTED THAT THE SEIZURE ACTIVITY BEGAN ON (B)(6) 2015. THE PATIENT WAS STARTED ON KEPPRA, AND THE PATIENT WAS DOING MUCH BETTER ON (B)(6) 2015. NO FURTHER PUMP WORK UP WAS PLANNED AT THIS TIME. THE DIAGNOSTICS/TROUBLESHOOTING/ACTIONS/INTERVENTIONS RELATED THE TO SYMPTOMS REMAINED UNKNOWN AT THE TIME OF THIS EVENT. FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN THE MISSING INFORMATION; IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE REPORTED THAT AFTER STARTING ON THE SEIZURE MEDICATION (KEPPRA), AND BY (B)(6) 2015 THE SYMPTOMS HAD RESOLVED. NO OTHER INTERVENTIONS WERE PERFORMED AND NO WORK UP RELATED TO THE PUMP WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815557 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Other