BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3980428 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13960
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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).

    Description of Event or Problem · 1

    ON (B)(4) 2014, INFORMATION WAS RECEIVED FROM A REPRESENTATIVE INDICATING THE PATIENT WAS SEEN IN THE CLINIC ((B)(6) 2014). THEIR DOSE WAS INCREASED BY 50% AS THEY WERE STILL WITHIN THE TITRATION PHASE ACCORDING TO THEIR HEALTHCARE PROVIDER (HCP). THE PATIENT LEFT THE CLINIC SOMETIME LATER THAT DAY AND REPORTED SYMPTOMS OF NAUSEA, VERTIGO, AND PALPITATIONS. THEY WERE INSTRUCTED BY THEIR PHYSICIAN TO GO TO THE ER TO RULE OUT OVERDOSE. THE PHYSICIAN DID NOT BELIEVE THERE WAS A PUMP MALFUNCTION. THE PUMP DOSE WAS REDUCED BACK DOWN TO 1.2 MG. THE PATIENT RETURNED AGAIN TO THE ER LATER THAT NIGHT AND THE PUMP WAS PROGRAMMED TO MINIMUM RATE DUE TO ONGOING SYMPTOMS. THE PATIENT HAD AN MRI THE NEXT DAY, THOUGH THE RESULTS WERE INCONCLUSIVE. THE PUMP WAS NOT READ UNTIL (B)(6) 2014. A MOTOR STALL APPEARED WHEN THE PATIENT HAD AN MRI, A TUBE SET MESSAGE OCCURRED 48 HOURS LATER, AND THEN A RECOVERY OCCURRED UPON INTERROGATION TODAY. THE PHYSICIAN REPORTED THE PATIENT DID NOT HAVE ANY WITHDRAWAL AND NO AUDIBLE ALARMS WERE REPORTED. THE MEDICATION INFUSED WAS MORPHINE. ON (B)(4) 2014 INFORMATION WAS RECEIVED FROM A REPRESENTATIVE INDICATING THE PATIENT MAY HAVE BEEN OVERDOSED. ON ((B)(6) 2014) WHEN THE PATIENT RETURNED TO THE CLINICIAN THE PATIENT LOOKED BETTER THAN THEY EVER HAD, AND THE PATIENT HAD NOT UNDERGONE A DOSE ADJUSTMENT OVER THE WEEKEND, WHICH CHALLENGED THE NOTION THAT THE PATIENT WAS SUFFERING AN OVERDOSE. ON (B)(6) 2014, THE PATIENT¿S PUMP WAS SET TO MINIMUM RATE OVER CONCERNS SURROUNDING THE TELEMETRY STALL REPORTED IN THE SAME CALL. THE PATIENT SUBSEQUENTLY COMPLAINED OF UNDERDOSE AND WITHDRAWAL SYMPTOMS. THE PATIENT WAS CURRENTLY UNDERGOING DOSE TITRATION; HOWEVER, THEY WERE A NO-SHOW TO THEIR WEDNESDAY APPOINTMENT THIS WEEK WHEN THE CLINICIAN PLANNED TO INCREASE THE INFUSION RATE ABOVE MINIMUM RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456667 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention