BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3111854 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07630
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CATHETER MODEL: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: UNK; CATHETER MODEL: 8709, LOT# L60026, IMPLANTED: (B)(6) 1999, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS HAVING EXTREME LEG PAIN SINCE MIDNIGHT LAST NIGHT AND IT HADN'T STOPPED. PATIENT FEEL ASLEEP BECAUSE 'PROBABLY THE PAIN WAS TOO MUCH AND HE FINALLY PASSED OUT FOR FOUR HOURS.' IT WAS ADDED THAT PATIENT THOUGHT IT WAS HAD SOMETHING TO DO WITH HIS CATHETER PRESSING AGAINST THE NERVES IN HIS LEG AND THE LEG WAS 'SHOCKINGLY CRAZY AND HYPERSENSITIVITY THROUGHOUT, THE TOP OF THE LEG AND IT HURTS LIKE YOU CANNOT IMAGINE, IMMENSE PAIN;' THIS MORNING PATIENT WOKE UP 'SCREAMING AT THE TOP OF MY LUNGS IN TEARS BECAUSE OF THE PAIN, THE PAIN IS EXCRUCIATING.' PATIENT DIDN'T GO TO THE ER AS THEY GIVE HIM STEROIDS AND HE CURRENTLY WAS PREDNISONE ONCE A DAY. IT WAS FURTHER STATED THAT 'PATIENT MIGHT HAVE A GRANULOMA OR SOMETHING AT THE TIP OF MY CATHETER THAT'S PRESSING AT NERVES.' THIS WAS BUT NOT CONFIRMED. DRUGS INFUSED VIA THE PUMP WERE MORPHINE, DILAUDID, FENTANYL, DROPERIDOL, CLONIDINE, AND BUPIVACAINE. IT WAS STATED THAT DROPERIDOL WAS IN THERE 'JUST A SMALL AMOUNT FOR NAUSEA AND THAT IT ENHANCES THE OTHER MEDICATIONS IN THE PUMP;' PATIENT TOOK 17.6 MG OF DROPERIDOL DRUG WITH THE DILAUDID. IT WAS ADDED THAT THE INFUSION SYSTEM HAS WORKED FOR THE PATIENT FOR THE LAST EIGHT YEARS AND PATIENT HAD BEEN AT THE SAME DOSAGE. PATIENT WAS IN A CONVALESCENT HOSPITAL NOW DISCHARGED FROM, BUT HE HAD TO LAY ON HIS BACK CONSISTENTLY FOR A WEEK, ALMOST TWO WEEKS 'IT'S LAYING ON THE NERVES AND THEM GETTING INFLAMED AND PATIENT WASN'T DOING ANYTHING.' PATIENT'S LEFT LEG GETS SPASTIC WHERE IT KICKS AND PATIENT HAD NO CONTROL OVER IT; IT DIDN'T HAPPEN THAT OFTEN BUT IF HE LAY IN BED TOO MUCH OR DIDN'T GET UP AND MOVE AROUND HIS LEG GETS STIFF. THIS WAS JUST HIS LEFT LEG. BUT NOW PATIENT HAD THE HYPERSENSITIVITY IN THE TOP OF HIS SKIN WHERE I CANNOT EVEN TOUCH HIS LEG. ON (B)(6) 2013 PATIENT HAD VISITED THE HEALTHCARE PROVIDER (HCP) AND A CHANGE TO CLONIDINE CONCENTRATION WAS DONE. IT WAS ADDED THAT PATIENT MENTIONED THE SIXTH DRUG AS DROPERID OL IN THE PUMP BUT IT WAS NOT REFLECTED IN THE PUMP LOGS, UNCLEAR IF IT WAS NOT CAPTURED IN THE PUMP LOGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212634 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other