BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3872113 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11558
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 19, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(6).

    Description of Event or Problem · 1

    THE PATIENT STATED THEY WERE IN THE ER LAST WEEK FOR A BLADDER INFECTION. AN ALARM WAS HEARD BUT TELEMETRY HAD NOT YET BEEN PERFORMED. THEY STATED THEY STARTED HEARING THIS SOUND ABOUT TWO OR THREE DAYS AGO. THE PATIENT STATED THAT THEY THOUGHT THEIR ALARM WAS GOING OFF, BUT THEY WERE NOT SURE BECAUSE, THEY WERE NOT SURE WHAT IT SOUNDED LIKE. THE PATIENT STATED ¿IT WAS LOW¿ AND MADE THEM WONDER ¿WHAT WAS THAT¿. THEY STATED IT SHOULD NOT BE BECAUSE THEIR REFILL DATE IS ON (B)(6) 2014. WHEN ASKED WHAT THE SOUND WAS, THEY INDICATED IT SOUNDED LIKE ¿DEE DOO DEE DOO¿. IT WAS THOUGHT TO BE A DUAL TONE ALARM, AND THE PATIENT CONFIRMED THAT THE CRITICAL ALARM SOUND, WHEN PLAYED, WAS THE SOUND THEY HAD BEEN HEARING. THE PATIENT STATED THEIR LEGS HAD BEEN HURTING AND STATED, IT WAS THEIR ONLY SYMPTOM THAT THEY COULD COME UP WITH. THIS SYMPTOM HAD BEEN OCCURRING WITHIN THE LAST COUPLE OF WEEKS. THE PATIENT INDICATED THEIR HEALTHCARE PROVIDER (HCP) HAD SET THEIR PUMP UP TO AUTOMATICALLY GIVE THE PATIENT A BOLUS BETWEEN 12:00 IN THE AFTERNOON AND 6:00 (TIME NOT SPECIFIED). THE PATIENT HAD A PROSPECTIVE CLINIC THAT COULD GET THE PATIENT IN BEFORE THEIR REFILL DATE ON (B)(6) 2014. THEY HAD LEFT ON BAD TERMS WITH THEIR PREVIOUS HCP. IT WAS UNCLEAR WHAT MEDICATIONS WERE INFUSED, THOUGH THE PATIENT INDICATED THAT THEY HAD RECEIVED MORPHINE AND ¿SOMETHING ELSE¿. ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM AN HCP INDICATING THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2014 FOR A REFILL, AND THERE WERE NO ISSUES AT THAT TIME. THE PATIENT LEFT THE CLINIC ON (B)(6) 2014 AND MOVED OUT OF STATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR PHYSICIAN OR MANUFACTURE REPRESENTATIVE. THE PATIENT HAD APPOINTMENTS SCHEDULE FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349026 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Other