BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3132083 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08284
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 29, 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 Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SEIZURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STAYED OVERNIGHT. THE PATIENT DID NOT FEEL THAT IT WAS RELATED TO THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) BECAUSE SHE HAD A WEIRD FEELING AND THOUGHT IT MAY BE HER ANXIETY. THE HEALTHCARE PROVIDER (HCP) WANTED THE PUMP CHECKED, BUT THE FACILITY WAS UNFAMILIAR WITH THE PUMP. THE PATIENT WAS AT THE BEGINNING OF A SEIZURE. IT WAS UNKNOWN IF THE SEIZURE WAS RELATED TO THE PUMP. THE PATIENT WAS STUTTERING, COULD NOT TALK, AND DID NOT FEEL WELL. THE PATIENT WAS IN DISTRESS BECAUSE THEY HAD NOT BEEN ABLE TO FIND AN HCP FOR REFILLS SINCE RELOCATING. THE PATIENT WAS PAST DUE FOR A REFILL, BUT HAD NOT HEARD ANY ALARMS. THE PATIENT WAS ¿OUT OF IT¿ AND ¿COULDN¿T THINK RIGHT.¿ THE PATIENT WAS GOING THROUGH WITHDRAWALS ¿OF SOME SORT.¿ THE PATIENT EXPERIENCED A CHANGE IN EFFECT, DIZZINESS, WEAKNESS, ACHES, POOR VISION, AND FLU-LIKE SYMPTOMS. THE PATIENT WAS FEVERISH, LOST WEIGHT, AND COULD BARELY WALK WITH A WALKER AND CANE. THE PATIENT ALSO WAS IN THE BEGINNING STAGES OF LUPUS AND IT WAS DETERIORATING. THE PATIENT DID NOT FEEL WELL AND HAD BEEN LYING DOWN. THE PATIENT WAS TAKING PERCOCET FOR BREAK THROUGH PAIN AS NEEDED. THE PATIENT¿S THERAPY WAS WORKING UNTIL THEY RELOCATED. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND CLONIDINE. IT WAS LATER REPORTED THAT THE PATIENT¿S LAST REFILL WAS (B)(6) 2013 AND THE LOW RESERVOIR ALARM DATE WAS (B)(6) 2013. AT THE LAST APPOINTMENT THE PATIENT WAS EXPERIENCING SOME PAIN IN HER BACK AND LEGS, BUT THE THERAPY WAS WORKING WELL TO CONTROL HER PAIN WITH NO SEVERE EXACERBATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236472 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization