BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3072718 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06737
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR PUMP REFILLED ON (B)(6) 2013 AND THE HOSPITAL FORGOT TO UPDATE THE PUMP TO SAY THAT IT WAS FILLED. THE HEALTH CARE PROVIDER (HCP) HAD TOLD THE PATIENT THAT THE PUMP "MIGHT START ALARMING ON SATURDAY THAT IT'S LOW" BECAUSE OF THE REFILL DATE INFORMATION NOT BEING UPDATED. THE PATIENT REPORTEDLY HAD AN APPOINTMENT SCHEDULED WITH THEIR HCP ON (B)(6) 2013. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174422 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR