BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202659 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-02924
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    May 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED A REACTION TO FENTANYL. PRIOR TO (B)(6) 2011, THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: NECK PAIN, PAIN BETWEEN THE SHOULDERS, PAIN IN THE LOWER AND MID BACK, HALLUCINATIONS, TWITCHING, AND THE PATIENT ¿FELT WEIRD IMMEDIATELY¿ AFTER STARTING TO USE A PTM. IT WAS ALSO REPORTED THAT THE PATIENT FELT LIKE SHE WAS ¿ON FIRE¿. ON (B)(6) 2011, THE PATIENT EXPERIENCED INCREASED DROWSINESS AND LOSS OF BALANCE. SIX DAYS LATER THE PUMP MEDICATION WAS CHANGED FROM FENTANYL TO HYDROMORPHONE AND DOSAGE WAS INCREASED; 11 MONTHS LATER IT WAS REPORTED THAT THE PATIENT NO LONGER HAD CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302800 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR