BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4162037 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19416
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID 8590-1, LOT# N424699, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N424699, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ON 10/13/2014 INFORMATION WAS RECEIVED FROM AN HCP INDICATING THE PATIENT'S INCISION LINE BLISTERED AND DEHISCED. THE CAUSE WAS UNKNOWN. THE CATHETER WAS ALSO REMOVED ON (B)(6) 2014. THE PATIENT'S MOTHER WAS DOCTORING THE WOUND WITH OINTMENTS. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT, AND THE ISSUE RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT¿S DOSE WAS REPORTEDLY TOO HIGH WHEN THEY CAME OUT OF SURGERY. THE PATIENT WAS SICK AND VOMITING, AND THEY WOULD NOT EAT OR DRINK. THEY WERE DROOLING WITH FOAM. THEY WERE GRINDING THEIR TEETH AND IN PAIN. THEY TRIED TO WORK THROUGH IT BECAUSE THE PUMP WAS HELPING WITH THE PATIENT¿S MOVEMENT. THE PATIENT WAS KEPT ON AN IV AND HOSPITALIZED FOR AN ADDITIONAL DAY. THEY WERE RELEASED FROM THE HOSPITAL ON (B)(6). THE PATIENT¿S BLADDER WAS EMPTY WHEN THEY LEFT THE HOSPITAL. THEY WERE SICK FOR ABOUT FOUR DAYS AND THEY WERE CONSTANTLY AT THE ER (B)(6). THE FIFTH TIME THEY WENT TO THE ER THE PATIENT HAD BLOOD IN THEIR URINE FROM CATHETERIZATION. THE PATIENT WAS DOING MUCH BETTER ON (B)(6) AND WENT TO SEE THEIR SURGEON THE NEXT DAY. THE MOTHER WAS CONCERNED ABOUT THERE BEING SO MUCH FLUID. THE SURGEON SAID THAT IT WOULD EVENTUALLY DRY UP. THE EMERGENCY ROOM DID NOT LOWER THE PATIENT¿S MEDICATION. THE PATIENT WAS NOT URINATING ON THEIR OWN. THEY LOOKED AT THE PATIENT¿S BLADDER AND IT WAS FULL FROM URINE. THE PATIENT HAD TO HAVE A CATHETER INSERTED. THEY HAD THOUGHT THE PATIENT WAS SWOLLEN FROM SURGERY, BUT IT WAS FROM THE URINE. THE PATIENT WAS SENT HOME WITHOUT A CATHETER, BUT EVENTUALLY REQUIRED THE CATHETER BE PLACED AGAIN AT THE HOSPITAL. THE PATIENT¿S DOSE WAS REDUCED, BUT IT WAS NOT WORKING AS FAR AS THE SPASTICITY WAS CONCERNED. THE HCP ADVISED THAT THE CATHETER STAY IN UNTIL THE PATIENT COULD URINATE ON THEIR OWN. THE BACLOFEN WAS REPORTEDLY TOO HIGH FOR THE PATIENT AND WAS A MUSCLE RELAXER. IT WAS REPORTEDLY RELAXING THE BLADDER AND THAT WAS THE REASON FOR THE PATIENT NOT URINATING ON THEIR OWN. THE PATIENT¿S MOTHER REQUESTED THE PATIENT¿S DOSE BE REDUCED. THE DOSE WAS REDUCED AND THE PATIENT WAS ABLE TO URINATE ON THEIR OWN. THE PATIENT DEVELOPED AN INFECTION SINCE THEIR STAPLES WERE REMOVED ON (B)(6), SEVEN DAYS AFTER THEIR IMPLANT SURGERY. THE INFECTION STARTED WITHIN TWENTY-FOUR HOURS OF THE STAPLES BEING REMOVED. THE PATIENT HAD REDNESS, AND THEY WERE IN THE EMERGENCY ROOM (ER) CONSTANTLY. AS OF (B)(6) 2014, THE PATIENT WAS HEALING AGAIN, BUT THEIR SKIN WAS VERY SOFT UNDERNEATH AS IF IT COULD TEAR UNDER WHERE THE CATHETER MET THE PUMP. EVENTUALLY THE SKIN AROUND THE INCISION STARTED SPREADING AND STRETCHING WHERE THE FLUID WAS AROUND THE PUMP. THE INCISION BURST, AND THE CATHETER BROKE THROUGH THE PATIENT¿S SKIN. THE FLUID WAS CLEAR. IT WAS A CLEAR PUSS AND NOT AN INFECTED PUSS. THE PATIENT¿S PUMP WAS REMOVED ON (B)(6) 2014 AS THE PATIENT HAD NUMEROUS INFECTIONS AROUND THEIR STOMACH AREA. THE MOTHER ALSO NOTED THEY DID NOT WANT TO DEAL WITH THE CATHETER INFECTION, BUT THEY LISTENED TO THEIR HCP. AS OF (B)(6) 2014, THE PATIENT DID NOT WALK, BUT THEY WERE REPORTEDLY ¿WONDERFUL NOW¿. THE PUMP CONTAINED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644594 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization| R