BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2251103 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07591
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    April 28, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 8596SC CONNECTOR HAD BEEN IMPLANTED 250 DAYS PAST EXPIRATION. IT EXPIRED 08/21/2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N258668012| CATHETER: MODEL 8596SC, LOT# N167860009| IMPLANTED:| EXPLANTED: