BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2935553 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01124
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    March 22, 2012
    Report Date
    March 12, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)((4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS "FLOATING AROUND" PATIENT'S BODY. THE PATIENT COULD NOT WALK STRAIGHT DUE TO THE PAIN CAUSED BY THE PUMP. SHE HAD TO WALK WITH SEVERE LEAN TO THE LEFT OR TO THE RIGHT. SHE HAD BEEN CRIPPLED OR NEARLY CRIPPLED. HER STOMACH FELT LIKE "A REALLY BAD TEAR IN THE SKIN AND SOMEONE PULLED THE BAND-AID OFF OF IT" WHEN SHE FELL ASLEEP WITH HER HEAD BACK. IT WAS CAUSING THE PATIENT'S NECK SURGERY TO FAIL. THE PATIENT'S VISION WAS NOT "DOING SO WELL" FROM WHAT SHE HAD BEEN GOING THROUGH. IT WAS "MESSING WITH HER VISION" ESPECIALLY WHEN SHE CRIED ABOUT IT. A PROBLEM WITH PERSONAL THERAPY MANAGER WAS ALSO REPORTED. FOR THE PAST THREE DAYS, THE PERSONAL THERAPY MANAGER WAS ONLY GIVEN THE PATIENT THREE BOLUSES. THE BOLUS REQUEST WAS DENIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PUMP HAD MOVED UNDER HER SKIN, FLIPPED, AND WAS NOW HITTING HER RIBS CAUSING HER TO WALK AT A "FORTY FIVE DEGREE ANGLE." IT WAS ALSO REPORTED THE PUMP WAS RUBBING UP AGAINST THE PATIENT'S VISCERA. THE REPORTER STATED, "IT'S CAUSING SOME INFLAMMATION TYPE THING" AND ALSO STATED, "IT'S JUST NOT WORKING WELL BECAUSE OF THE POSITION IT'S IN IS CAUSING PAIN." IT WAS REPORTED, "IT WAS NEVER MOUNTED. IT WAS CUT TOO HIGH AND WHEN THEY PUT IT IN IT WASN'T MOUNTED." THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER INDICATE THE PUMP WAS PUT IN A FAULTY WAY, IT CAME OUT AND HAD TO BE RE-INSTALLED. IT WAS NOTED ¿IT CRIPPLED ME PRETTY MUCH.¿ IT WAS ALSO REPORTED ¿THEY HAD TO PUT A ROD¿ IN THE PATIENT¿S SPINE. THIS ALL BEGAN ABOUT 6-7 YEARS AGO. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41503 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention