BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2904043 · Received January 9, 2013

    Report

    Report Number
    6000030-2013-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER SERIAL # UNKNOWN, IMPLANTED: (B)(6) 1993, EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED SHE HAD A DEFECTIVE PUMP IN 1993. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10710 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8611H

    Patients

    Seq Age Sex Outcome Treatment
    1