BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023453 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01729
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 21, 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
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED AN UNDERDOSE SINCE THE LAST PUMP REFILL. THE PT HAD MISSED A PUMP REFILL SESSION IN (B)(6) 2010. APPROX THREE MONTHS LATER, A VOLUME DISCREPANCY OCCURRED. THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME; SPECIFIC VOLUMES WERE NOT PROVIDED. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE FENTANYL AND MARCAINE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 27 YR CATHETER: MODEL 8731SC, LOT # N184085011| EXPLANTED:| IMPLANTED: