BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2251085 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07576
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 2, 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
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THERE WAS A "MISSED REFILL DATE AND PUMP WENT EMPTY ON (B)(6) 2011." THE PUMP ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE CRITICAL ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE PATIENT EXPERIENCED NO SYMPTOMS UNTIL (B)(6) 2011, WHEN THE PATIENT'S MOTHER NOTICED "SOME TIGHTNESS". AS OF (B)(6) 2011, THE PATIENT WAS AT THE HCP CLINIC AND A PUMP REFILL PROCEDURE WAS PLANNED. IT WAS LATER REPORTED THE PUMP CONTAINED LIORESAL. THE PUMP WAS REFILLED AND THE HCP DECIDED TO REDUCE THE PUMP DOSE BY 20 PERCENT. ON (B)(6) 2011, IT WAS REPORTED THE PATIENT'S STATUS WAS "GOOD."

    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 18 YR EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N235666001| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N204183019