BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 7149080 · Received December 27, 2017

    Report

    Report Number
    3004209178-2017-26688
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Report Date
    January 9, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508149
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703, LOT# J92-102766, PRODUCT TYPE CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS RECEIVING 1240.0MCG/ML FENTANYL AT 350.1MCG/DAY, 434.0MCG/ML CLONIDINE AT 122.53MCG/DAY, AND 15.7MG/ML BUPIVACAINE 4.443MG/DAY VIA AN IMPLANTABLE INFUSION PUMP FOR SPINAL PAIN. IT WAS NOTED IN THE PUMP LOGS THAT THE CATHETER DID NOT EASILY ASPIRATE. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP). IT WAS REPORTED THAT THE HCP HAD NO IDEA WHY THERE WAS A NOTE IN THE LOGS STATING THE EXISTING CATHETER DOES NOT EASILY ASPIRATE. THE NOTE HAD BEEN IN THE LOGS SINCE 2016. THERE WAS NO KNOWN EVENT WITH THE CATHETER. THE HCP DID NOT HAVE ANY INFORMATION ABOUT IT AND DID NOT KNOW OF ANY EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP).IT WAS REPORTED THAT THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928008 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169508149

    Patients

    Seq Age Sex Outcome Treatment
    1