BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2092153 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-03147
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 3, 2011
    Report Date
    April 12, 2011
    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
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A PUMP REFILL ON (B)(6) 2011, AND THEN EXPERIENCED WITHDRAWAL SYMPTOMS ON (B)(6) 2011, WITH A "REALLY BAD HEADACHE AND NAUSEA" FOR A "COUPLE OF DAYS". ORAL MEDICATIONS WERE INCREASED; THEY HAD NOT SUSPECTED THE PATIENT'S PUMP AS THE ISSUE DUE TO JUST HAVING HER PUMP REFILLED. THEY THOUGHT THAT THE PATIENT HAD GALLBLADDER PROBLEMS AND THE FLU. ON (B)(6) 2011, THE PATIENT HAD A PUMP REFILL AND THERE WAS A VOLUME DISCREPANCY. THE ACTUAL RESIDUAL VOLUME WAS 28ML AND THE EXPECTED RESIDUAL VOLUME IN THE PATIENT'S PUMP WAS 2ML. A DYE STUDY TEST WAS PERFORMED LAST WEEK AND THE CATHETER TUBING WAS NOTED TO BE "ALL KNOTTED". THE PATIENT WAS WAITING TO HEAR BACK FROM THEIR HCP. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE DILAUDID AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N253038001| PROGRAMMER: MODEL 8835, LOT# NPG018195N| EXPLANTED: