BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3950184 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13354
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE ALARM WAS A LOW RESERVOIR ALARM.

    Description of Event or Problem · 1

    THE PATIENT MISSED THE PUMP REFILL DATE OF (B)(6) 2014 AS SHE WAS IN (B)(6) AN EXTRA 8 DAYS DUE TO THE PASSING OF HER FATHER. THE PATIENT WAS UNSURE OF THE DRUGS USED IN THE PUMP OR THE DOSE AND CONCENTRATION AS ALL OF HER INFORMATION WAS AT HOME. THE PUMP MEDICATION HAD BEEN INCREASED DUE TO ¿SOME ACCIDENT SHE HAD 6 MONTHS AGO¿. THE PATIENT STARTED TO REALIZE THAT THERE WAS A PROBLEM TWO DAYS AGO. THE PATIENT EXPERIENCED WITHDRAWAL, WAS EXTREMELY DIZZY, LIGHTHEADED, HAD HOT/COLD SWEATS, CHEST PAINS AND MUSCULAR CRAMPING. THE PATIENT WAS WORKING WITH A TRAVEL CONCIERGE AND HAD SEEN TWO DOCTORS; HOWEVER, DELAYS OCCURRED. THE PATIENT WAS WORKING ON EXPEDITING TRAVEL ARRANGEMENTS DUE TO THE SITUATION; HOWEVER, SHE WAS GOING TO GO TO THE EMERGENCY ROOM. ADDITIONAL INFORMATION INDICATED THAT A PUMP ALARM HAD OCCURRED. THE PATIENT WAS OUT ¿OF THE COUNTRY¿ AND WAS IN THE HOSPITAL RECEIVING MORPHINE FOR WITHDRAWAL. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID, CLONIDINE, MARCAINE, AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428985 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R