BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3898262 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12133
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER; PRODUCT ID 8590-1, LOT# N102656, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    DURING A PUMP REPLACEMENT THE DOCTOR WAS UNABLE TO ASPIRATE THE EXISTING CATHETER. THEY DID NOT HAVE AN OPTION TO REPLACE THE CATHETER. THERE WAS NO THERAPY ISSUE PRIOR TO THE PUMP REPLACEMENT. THE MEDICATION INFUSED WAS GABLOFEN. AS OF (B)(6) 2014 THE REPRESENTATIVE INDICATED THAT THERE WAS NO DETERMINATION OF WHY THEY COULD NOT ASPIRATE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375111 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR