BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3885100 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11846
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    February 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A PUMP REPLACEMENT DUE TO SPASTICITY. THE PATIENT WAS "FAIRLY WELL" POSTOPERATIVELY. THE PATIENT HAD NO MOTIVATION TO GET OUT OF BED. THE PATIENT WAS ABLE TO GET UP AND TOLERATE PHYSICAL THERAPY. THE PATIENT HAD PAIN AND THE MEDICATIONS WERE BEING ADJUSTED. IT WAS THOUGHT THE PATIENT WAS A GOOD CANDIDATE TO DISMISS TO HOME. THE PATIENTS CURRENT STATUS WAS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN IN PAIN AND HAD A LOT OF TROUBLE WITH HER PUMP BEGINNING AT THE TIME OF IMPLANT. THE PATIENT HAD GONE TO THE HOSPITAL 3 WEEKS AGO DUE TO THE PAIN. THEY HAD BEEN TRYING TO REGULATE THE BACLOFEN AND PUT IT IN A LITTLE AT A TIME. THE PATIENT WAS NOTED TO BE ALLERGIC TO NICKEL AND THEY THOUGHT THAT MIGHT BE THE ISSUE. THE HEALTHCARE PROFESSIONAL (HCP) DID NO KNOW WHERE THE PAIN WAS COMING FROM OR WHAT WAS CAUSING IT. THIS WEEKEND, THE PATIENT WAS IN SO MUCH PAIN THEY GAVE HER SOMETHING AT THE HOME WHERE SHE GETS HEALTH CARE. THE PATIENT HAD WANTED IT TAKEN OUT BUT WAS TOLD "NO¿. IT MIGHT NOT EVEN BE THE PUMP". IT WAS STATED "SHE MAY NOT BEGETTING ENOUGH BACLOFEN OR SHE MIGHT BE GETTING TOO MUCH". IT WAS LATER MENTIONED THAT THEY THOUGHT THE REASON THE PATIENT ENDED UP IN THE HOSPITAL 3 WEEKS AGO WAS BECAUSE THEY GAVE HER THE WRONG MEDICATION IN THE ER. THE PATIENT WAS "WAY OUT THERE.. SEEING LITTLE KITTIES AND LITTLE BABIES AND GRABBING IN THE AIR¿.IT WAS A BAD TRIP". IT WAS STATED "IT MUST HAVE BEEN THE MEDICATION SHE WAS ALLERGIC TO AND THEN WHEN THEY TOOK HER OFF OF IT, SHE STARTED GETTING BETTER. THE PUMP CONTAINED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361344 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Other| R