BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8740385 · Received June 27, 2019

    Report

    Report Number
    3004209178-2019-12522
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    February 12, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630512
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING 250 MCG/ML OF MORPHINE AT 140 MCG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NOT PROVIDED. IT WAS REPORTED THE PATIENT HAD A POCKET REVISION SURGERY SCHEDULED FOR (B)(6) "201919" BECAUSE HER PUMP WAS FLIPPING IN THE POCKET. PRIOR TO THE REVISION THE REP WAS INFORMED BY THE PATIENT THAT THE PATIENT NO LONGER WANTED THE PUMP AND WAS GOING TO HAVE IT REMOVED RATHER THAN HAVE THE POCKET REVISED. THE PATIENT STATED SHE DID NOT FEEL LIKE IT WAS HELPING HER PAIN AND SHE NO LONGER WANTED THE INFUSION SYSTEM IMPLANTED. A LARGE AMOUNT OF FLUID CAME OUT OF THE PUMP POCKET AT THE TIME OF THE INCISION. THE DOCTOR EXPLANTED THE PUMP AND CATHETER AND SENT THE DEVICES TO MICROBIOLOGY TO DETERMINE IF AN INFECTION WAS PRESENT. REGARDING ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE, IT WAS REPORTED THE PATIENT DID NOT REPORT ANY FALLS OR TRAUMA. REGARDING DIAGNOSTICS/TROUBLESHOOTING PERFORMED, THE PUMP AND CATHETER WERE SENT TO MICROBIOLOGY TO DETERMINE IF AN INFECTION WAS PRESENT. NO OTHER INTERVENTIONS WERE TAKEN. IT WAS INDICATED THE HOSPITAL WAS IN POSSESSION OF THE EXPLANTED PUMP AND CATHETER AND IT WAS UNKNOWN IF THE DEVICES WOULD BE RETURNED TO THE MANUFACTURER. IT WAS REPORTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT, (B)(6) 2019. THE PATIENT'S STATUS WAS PROVIDED AS ALIVE - NO INJURY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. OTHER MEDICATIONS BEING TAKEN AT THE TIME OF THE EVENT, MEDICAL HISTORY, AND PATIENT WEIGHT WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). THE REP REPORTED THE EXACT DATE WHEN THE PUMP BEGAN FLIPPING IN THE POCKET WAS UNKNOWN. REGARDING THE LACK OF THERAPY, THE PATIENT STATED SHE DID NOT BELIEVE SHE EVER RECEIVED ADEQUATE PAIN RELIEF FROM THE BEGINNING. IT HAD BEEN CONFIRMED THAT THERE WAS NO INFECTION PRESENT FROM THE FLUID CULTURE. IT WAS INDICATED THE INFORMATION HAD BEEN CONFIRMED WITH THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534306 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169630512

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention