BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3821388 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09278
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    February 5, 2019
    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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN A SEROMA AT THE DEVICE POCKET. IT WAS INDICATED THAT SURGICAL INTERVENTION WAS PERFORMED TO PLACE A MESH OVER THE PUMP. AT THE TIME OF REPORT, THERE WAS NO PATIENT INJURY. FIFTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING SWELLING AND DRAINAGE AT THE POCKET SITE. THE REPORTER STATED THAT THE PUMP HAD PREVIOUSLY BEEN IMPLANTED IN THE RIGHT, LOWER QUADRANT OF THE ABDOMEN AND THE SAME PROBLEM WAS BEING EXPERIENCED. CULTURES WERE PERFORMED AND THE RESULTS WERE GOOD, SHOWING NO GROWTH. THE HEALTHCARE PROVIDER (HCP) HAD REQUESTED AN ALLERGY TEST, BUT WAS DENIED BY INSURANCE. AT THAT TIME, THE PUMP WAS EXPLANTED AND REIMPLANTED IN THE LEFT, LOWER QUADRANT. THE HCP WAS HOPING THAT THE MESH POUCH WOULD HELP WITH THE PATIENT¿S SYMPTOMS, THOUGH, IT WAS INDICATED THAT THE POCKET SITE HAD CONTINUED TO OOZE. IT WAS ALSO NOTED THAT THE PATIENT WAS IN THE HOSPITAL WITH A FEVER; HOWEVER, THEY WERE THINKING THAT IT WAS FROM A VIRAL INFECTION THAT WAS NOT RELATED TO THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    ON (B)(6) 2019 ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER WHO REPORTED THAT THE NEW PHYSICIAN THEY WERE SEEING WANTED TO ¿RE-DO IT¿ AND PUT A PAIN PUMP IN. PER THE REPORTER, THEY HAD 7 SURGERIES IN 10 MONTHS AND ¿NEVER GOT IT MOUNTED RIGHT¿. THE PHYSICIAN THE PATIENT WAS SEEING NOW WAS THINKING ABOUT RE-IMPLANTING A PUMP BECAUSE THE PAIN PUMP WORKED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300222 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention