BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3051115 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05943
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8840, LOT# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP MEMORY ERROR OCCURRED DUE TO INCOMPATIBLE SOFTWARE WITH THE NEWLY IMPLANTED ASCENDA CATHETER. THE PATIENT WAS IMPLANTED APPROXIMATELY ONE MONTH AGO, AND AS OF THE DATE OF THIS REPORT, THE HEALTHCARE PROVIDER (HCP) WAS ATTEMPTING TO INCREASE THE DOSE. THE HCP WAS TO USE ANOTHER PROGRAMMER TO TEMPORARILY UPDATE THE PATIENT AND CORRECT THE CATHETER INFORMATION WHEN HE GETS THE NEW CARD. THE PUMP SYSTEM WAS BEING USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THAT THE HCP WAS ABLE TO UPDATE THE PUMP WITH ANOTHER PROGRAMMER THAT HAD THE UPDATED SOFTWARE. THERE WERE NO PATIENT SYMPTOMS AND NO PATIENT INJURY RELATED TO THIS EVENT. IT WAS NOTED THAT THE DRUG IN THE PUMP WAS GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152437 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1