BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3051301 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05946
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# L80788, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THERE WAS A PROBLEM WITH THE PUMP, THAT THERE WAS A KINK OR BLOCKAGE AND THEY HAD NOT BEEN GETTING DRUG DELIVERY. A DYE TEST WAS ATTEMPTED AND THEY TRIED TO EXTRACT CEREBROSPINAL FLUID (CSF); HOWEVER, IT WAS NOTED THAT THEY 'COULD NOT EVEN GET IN THERE.' THE PATIENT HAD WORSENING/INCREASED PAIN FOR A 'NUMBER OF YEARS' AND HAD NO BENEFIT FROM INCREASES OR RATE INCREASES. THE PATIENT SUSPECTED THE PUMP WAS NOT WORKING 'FOR SOME TIME NOW.' THE PATIENT HAD BEEN SEEKING ALTERNATIVE WAYS TO CONTROL THE PAIN. THE PATIENT PLANNED TO FOLLOW UP WITH THE PHYSICIAN IN THE FUTURE. THE PUMP SYSTEM WAS BEING USED TO DELIVER FENTANYL AND BUPIVACAINE. 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
    153646 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1