BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3130304 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08188
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 29, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON THE EVENING OF (B)(6) FOR AN UNDERDOSE RESULTING IN INTRACTABLE PAIN FOLLOWING A ROUTINE PUMP REPLACEMENT THE DAY BEFORE. IT WAS NOTED THAT THERE WAS 36.5CM (0.08ML) DISTAL SECTION OF CATHETER THAT HAD DRUG AND A 19CM (0.04ML) SECTION OF EMPTY CATHETER THAT WAS ADDED WHEN PUMP WAS CHANGED. ABOUT ONE MONTH LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN, BUT WAS ATTRIBUTED TO A CATHETER KINK. IT WAS REPORTED THAT THE KINK WAS SEEN ON (B)(6) DURING A CATHETER DYE STUDY. THE PATIENT HAD EXPERIENCED INCREASED PAIN. IT WAS NOTED THAT A SURGICAL REVISION WAS PERFORMED. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED, BUT HE HAD RECOVERED WITHOUT SEQUELA. THE DEVICE WAS DELIVERING MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231031 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention