BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170917 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10406
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 22, 2013
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD LOSS 150 LBS IN THE LAST YEAR AND NOTED THAT THE PUMP WAS FLIPPING. IT WAS STATED THAT PUMP WAS SUPPOSED TO BE ANCHORED DOWN BUT THE "PUMP FLIPS LIKE CRAZY" ANYTHING PATIENT SAT DOWN OR STAND UP. IT WAS INDICATED THAT PATIENT COULD LITERALLY ¿FLIP THE PUMP IN A CIRCLE IN CASE IT WAS KINKING OR PULLING¿ IT WAS ADDED THAT 3-4DAYS AGO FROM THE DAY OF THIS REPORT, PATIENT FELT EXTREMELY DIZZY WHENEVER STANDING UP. IT WAS ALSO REPORTED THAT PATIENT WAS SORE AND ¿THE PUMP WAS STICKING OUT¿. IT WAS REPORTED THAT PATIENT WAS ENCOURAGED TO USE AN ABDOMINAL BINDER AND NOT TO BE PLAYING WITH THE PUMP TO AVOID KINKING OF CATHETER. THE PUMP WAS BEING USED TO DELIVER PRIALT (ZICONOTIDE). IT WAS LATER REPORTED THAT PATIENT WANTED TO KNOW WHAT THE DANGER OF THE PUMP NOT SUTURED DOWN AND FELT LIKE THE PUMP WAS NOT ANCHORED AT ALL. IT WAS INDICATED THAT, SUNDAY THE (B)(6) 2013 PATIENT STATED EXPERIENCING THE FOLLOWING SYMPTOMS: VERY DIZZY, MOUTH TASTE "MEDICINY" AND KEPT GOING NUMB, STIFF IN THE NECK AND IN THE LEFT SIDE OF THE BODY AND WAS REALLY PAINFUL. IT WAS ADDED THAT PATIENT¿S BACK HURTING SYMPTOMS ARE RETURNING. IT WAS ALSO REPORTED THAT PATIENT HAD TO GO TO THE ER TODAY BECAUSE OF THE DIZZINESS AND THE TASTINESS IN THE MOUTH. IT WAS NOTED THAT PATIENT MOUTH WAS NUMB AFTER EATING SOMETHING. HEALTH CARE PROVIDER WAS GOING TO SET APPOINTMENT FOR PATIENT TO BE SEEN ON FRIDAY. THE PUMP WAS BEING USED TO DELIVER PRIALT (ZICONOTIDE). IT WAS LATER REPORTED PATIENT HAD A PUMP INVERSION (FLIPPING) POSSIBLE 200G AFFECT. IT WAS INDICATED THAT PATIENT HAD A REVISION AND THE PUMP WAS REATTACHED TO THE FASCIA. IT WAS NOTED THAT PATIENT EXPERIENCED SYMPTOMS OF DIZZINESS AND FUNNY TASTE. THE PATIENT OUTCOME WAS NOTED AS ¿NO INJURY¿.THE PUMP WAS BEING USED TO DELIVER PRIALT (ZICONOTIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271726 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention