BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3840417 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09855
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 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
    MT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014-05-07 THE PATIENT MOVED TO A NURSING HOME. IT WAS FURTHER REPORTED THERE WAS ONE TIME SEVERAL MONTHS AGO THE PATIENT TOLD THE NURSING HOME HE WAS TOO TIRED TO GO GET HIS REFILL DONE. THE CARETAKER CALLED THE STAFF THE NEXT DAY AND INFORMED THEM THE PATIENT HAD TO ATTEND HIS SCHEDULED REFILL APPOINTMENTS. IT WAS NOTED ON (B)(6) 2014 THE NURSING HOME MADE AN EMERGENCY APPOINTMENT TO GET HIS PUMP REFILLED BECAUSE HIS ALARM WAS GOING OFF AND THE PUMP DID GET REFILLED ON (B)(6) 2014. IT WAS UNKNOWN WHEN THE ALARM STARTED TO GO OFF. ALSO ON (B)(6) 2014 THE CARETAKER WAS GOING TO TAKE THE PATIENT TO THE AUDIOLOGIST, BUT THEY SAID HE HAD TO GO TO THE PAIN CLINIC INSTEAD FOR A REFILL. IT WAS REPORTED THEY DID NOT SAY THEY HEARD HIS ALARM, BUT THE REPORTER THOUGHT THEY LOOKED IN THE FILE AND SAW THE ALARM DATE. IT WAS UNKNOWN WHETHER OR NOT THEY ACTUALLY HEARD AN ALARM. THE PUMP WAS BEING USED TO DELIVER INTRATHECAL BACLOFEN THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS EXPERIENCING DROWSINESS AND THE LOW RESERVOIR ALARM WAS OCCURRING DUE TO A MISSED APPOINTMENT. IT WAS NOTED THE PATIENT WAS DOING ¿FINE¿ NOW AND WAS RECEIVING EFFECTIVE THERAPY. THE PUMP WAS BEING USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317987 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR