BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3052368 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-05996
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT# N171041003, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8840, LOT# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013 AS THE PATIENT WAS "NOT FEELING GOOD' AND HAD MILD WITHDRAWALS. THE PATIENT'S PERSONAL THERAPY MANAGER (PTM) REPORTEDLY NOTED THE PATIENT SHOULD BE FINE 'FOR ANOTHER TWO WEEKS OR UNTIL LATE (B)(6).' HOWEVER, NO MEDICINE WAS ASPIRATED AS THE PUMP WAS EMPTY. THE PUMP WAS RINSED AND 10 MILLILITERS (ML) WERE ASPIRATED WITH THE RINSE AS EXPECTED. AFTER HOWEVER, DIFFICULTIES OCCURRED DURING THE ATTEMPT TO REFILL THE PUMP. ONLY 18 ML COULD BE FILLED RATHER THAN THE FULL 20ML. IT WAS LATER REPORTED THAT THE HEALTH CARE PROVIDERS (HCP) DECIDED THAT IT MIGHT HAVE BEEN A PROGRAMMING ERROR ON THE PATIENT'S PREVIOUS REFILL THAT CAUSED THE PATIENT TO RUN OUT OF THE DRUG. THE HCP ELECTED TO MONITOR THE PATIENT CLOSELY AND BRING THE PATIENT IN ON THE REFILL INDICATED AS IF THE PATIENT USED ALL THE PTM DOSES, REGARDLESS OF THE DATE INDICATED BY THE PTM. THE PATIENT WAS INSTRUCTED TO NOTIFY THE HCP IF ANY WITHDRAWAL SYMPTOMS OCCURRED. ALL OTHER PROCEDURES, SUCH AS DYE OR ROTOR STUDIES WERE POSTPONED FOR NOW. THE PATIENT WAS REPORTEDLY 'DOING WELL AS HE HAD BEEN THE FOUR YEARS BEFORE THIS INCIDENT.' THIS DEVICE SYSTEM DELIVERED MORPHINE AND FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156253 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1