BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3830471 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09574
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP RAN OUT. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED OR REQUIRED. THE PRODUCT REMAINED INTACT WITH NO FUNCTIONAL ISSUES. THE REFILL DATE WAS SKIPPED, MISSED OR INCORRECTLY SCHEDULED. THE PATIENT WAS NONVERBAL. THERE WERE RED RAISED AREAS APPEARING LIKE A RASH ON THE ARMS, FACE AND CHEST. THE PATIENT HAD RESTLESSNESS AND ¿MUSCLE FASO IMAGINE¿ WAS REPORTED. THERE WAS NO FRANK INCREASE IN SPASTICITY. THE REDNESS WAS RESOLVING AFTER SECOND BOLUS. THE PHYSICIAN WAS TREATING MEDICALLY WITH ADJUNCTIVE MEDICATIONS. THE PATIENT WAS INPATIENT AND WAS REFILLED AS WELL AS INCREASED TO 175 MICROGRAMS PER DAY FROM 160 MICROGRAMS PER DAY. THERE WAS A FAVORABLE RESPONSE. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ THE SYSTEM WAS BEING USED TO DELIVER LIORESAL. IT WAS REPORTED THE NEXT DAY THAT THE PATIENT WAS DOING WELL POST-WITHDRAWAL EPISODE AND RELAXED. THE REDNESS DISSIPATED AND THERE W AS NO AGITATION. THE DOSE WAS ADJUSTED BACK TO 160 MICROGRAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308520 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Hospitalization