BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1983072 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00876
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), (HEART VALVE ISSUES), (B)(4).

    Description of Event or Problem · 1

    PER THE REPORTER, AT THE END OF (B)(6) 2010, THE DOCTOR STATED, THE PUMP WAS EMPTY; THE PUMP DID NOT ALARM. THE PATIENT EXPERIENCED A LOT OF PAIN. THE PUMP WAS FILLED. DURING THE LAST PUMP REFILL, "IT WAS HORRIBLE" TRYING TO GET THE REFILL DONE. SPECIFIC ISSUES WITH THE REFILL WERE NOT REPORTED. THE PUMP CONTAINED MORPHINE 10 MG/ML. IN (B)(6) 2010, THE PUMP WAS ALARMING. THE PATIENT EXPERIENCED SWEATS, A PINS AND NEEDLES SENSATION IN FEET WHEN FEET HANG OVER THE BED, WHITE BUMPS "LIKE ZITS" ALL OVER THE BODY, PEELING AND CRACKING SKIN, SWOLLEN FEET AND LEGS, SORENESS, A LINE "COMING UP ARM 4 INCHES LONG", AND CONFUSION. ON (B)(6) 2011, THE MORPHINE WAS INCREASED FROM 4 MG/DAY TO 5 MG/DAY. THE PATIENT SLEPT FOR 2 DAYS STRAIGHT. ON (B)(6) 2011, THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO NOT FEELING WELL. THE PATIENT FELT "SURGES" OF MEDICATION AND FELT LIKE HE WAS GETTING TOO MUCH. THE PATIENT WAS DISCHARGED FROM THE EMERGENCY ROOM. ON (B)(6) OR (B)(6) 2011, THE PATIENT WENT AGAIN TO THE EMERGENCY ROOM. AT THAT TIME, HIS LEGS WERE SWOLLEN AND RED "LIKE PLASTIC". THE DOCTOR TOLD THE PATIENT, HE HAD (B)(6). THE PATIENT EXPERIENCED MOOD SWINGS AND "DROPPING EVERYTHING". THE PATIENT WAS GIVEN ANTIBIOTICS. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH TACHYCARDIA AND HEART VALVE ISSUES. THE PATIENT THEN LEFT THE HOSPITAL AMA (AGAINST MEDICAL ADVICE). THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL(B)(6) 2011. ON (B)(6) 2011, THE PATIENT EXPERIENCED SWELLING, SORENESS, PINCHING AND WEAKNESS. THE PATIENT WAS OOZING GREEN FROM SKIN. THE SKIN WAS "SINKING" IN THE MIDDLE OF THE PUMP. THE SYMPTOMS BEGAN TO APPEAR ON THE RIGHT SIDE OF BACK AND SPINE AND THEN MOVED TO THE LEFT. ON (B)(6) 2011, THE PUMP WAS INTERROGATED AND WAS FUNCTIONING AND SHOWED NO PENDING ALARMS. PER THE REPORTER, THE PUMP PHYSICIAN INSTRUCTED THE PATIENT TO HAVE A DYE STUDY TO CHECK CATHETER PATENCY. THE PATIENT WAS NOT EXPERIENCING ANY WITHDRAWAL OR OVERDOSE. IT DID NOT APPEAR THAT THE INFECTION WAS AT THE PUMP POCKET. ON (B)(6) 2011, THE PATIENT WANTED THE PUMP DOSAGE SLOWLY DECREASED SO EVENTUALLY THE PUMP COULD BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N173704015| IMPLANTED: