BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2193399 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05406
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 22, 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 THE PT HAD EXPIRED PUMP THAT WAS IMPLANTED. THE USE BY DATE WAS (B)(6) 2011 AND IT WAS IMPLANTED ON (B)(6) 2011. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED.

    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 69 YR IMPLANTED:| CATHETER: MODEL 8731SC, LOT #N220611002| EXPLANTED: