BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1923268 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09114
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 19, 2010
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT'S DEVICE HAD "NOT BEEN WORKING FOR TWO MONTHS." IT WAS STATED, THE PT'S HEALTH CARE PROVIDER (HCP) HAD TOLD THE PT, HER CATHETER OR CATHETERS NEEDED TO BE FIXED. IT WAS STATED THAT IF SHE "EATS OR DRINKS SOMETHING HOT IT BURNS." IT WAS ALSO STATED THAT, WHEN THE PUMP WAS STILL ON, HER ABDOMEN BURNED LIKE IT WAS "ON FIRE" FROM FRONT TO BACK AND WAS "EXTREMELY PAINFUL." THE PT WAS ON ORAL MEDICATION AND PATCHES. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVICAINE AND DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# 115978020