BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2625276 · Received June 21, 2012

    Report

    Report Number
    3004209178-2012-04745
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Report Date
    May 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK. CATHETER: MODEL: 8590-8, LOT# N267836, IMPLANTED: (B)(6) 2011, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS IMPLANTED AFTER THE USE BEFORE DATE (UBD). THE UBD WAS (B)(4) 2012; 65 DAYS EXPIRED AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR