BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3083195 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07025
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 2, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMPTY RESERVOIR ALARM HAD OCCURRED ON (B)(6) WITH THE LOW RESERVOIR ALARM OCCURRING SIX DAYS PRIOR. IT WAS STATED THAT THE PATIENT LOOKED LIKE SHE WAS GOING THROUGH SOME WITHDRAWAL. SHE HAD COME INTO THE HOSPITAL OVER THE PRIOR WEEKEND. THE PATIENT HAD MISSED HER REFILL DATE DUE TO AN "ALTERCATION" FOLLOWED BY HER VOLUNTARILY LEAVING. NO NEW APPOINTMENT HAD BEEN SCHEDULED AFTER THAT. AT THE TIME OF REPORT, THE PUMP HAD BEEN SET IN MINIMUM RATE AND THE PATIENT WOULD BE TREATED WITH INTRAVENOUS MEDICATIONS FOR THE NIGHT. THE NEXT DAY THE PUMP WOULD BE REFILLED USING FLUOROSCOPY AND THEN WOULD BE REPROGRAMMED BACK TO THE PATIENT'S DAILY DOSE. THE DEVICE SYSTEM WAS INFUSING MORPHINE, BUPIVACAINE, AND CLONIDINE. THREE DAYS LATER, IT WAS REPORTED THAT THE PUMP HAD BEEN REFILLED ON THE DAY FOLLOWING THE INITIAL REPORT. IT WAS UNKNOWN IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183615 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization