BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1893173 · Received November 2, 2010

    Report

    Report Number
    3004209178-2010-08749
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    June 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT HAD AN INCREASE IN SPASMS. A VOLUME DISCREPANCY WAS REPORTED. THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN EXPECTED. IT WAS STATED THE RESIDUAL VOLUME IN THE PATIENT'S PUMP HAD BEEN INCREASING AT REFILLS. A (B)(6) WAS PERFORMED "THREE MONTHS AGO" AND REVEALED NO PROBLEMS. NO ALARMS WERE REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. 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 44 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# J11595R22| IMPLANTED: