BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6838257 · Received September 1, 2017

    Report

    Report Number
    3004209178-2017-18601
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    January 1, 2014
    Report Date
    September 29, 2017
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL VIA BUSINESS PARTNERS REPORTED THE PATIENT MEDICAL HISTORY INCLUDED NON -MALIGNANT PAIN, FAILED BACK SYNDROME, IMPLANTATION OF AN ITREL 3, IN-LINE EXTENSION, PISCES-QUAD, ITREL EZ (MODEL NUMBER 7425, 7495-25, 3888-28, 7434-E IMPLANTED ON (B)(6)2001), AN ITREL 3, QUAD-LOW IMPEDANCE, PISCES-QUAD (MODEL NUMBER 7425, 7495LZ25, 3888-28 IMPLANTED ON 2002-AUG-13), AN ITREL 3 (MODEL NUMBER 7425 IMPLANTED ON (B)(6)2004) AND A SYNCHROMED II, INDURA SUTURELESS (MODEL NUMBER 8637-20, 8709SC IMPLANTED ON (B)(6)JUN). ON (B)(6)2013, THE PATIENT¿S TREATMENT INCLUDED BACLOFEN 500 MCG/ML AT 65 MCG/DAY FOR THE OFF LABEL INDICATION OF NON-MALIGNANT PAIN AND FAILED BACK SYNDROME AS WELL AS SUSPECT PRODUCTS (PREVIOUSLY NOTED AS CONCOMITANT MEDICATIONS) INCLUDING CLONIDINE 500 MCG/ML AT 162 MCG/DAY, BUPIVACAINE 20 MG/ML AT 6.5 MG/DAY AND MORPHINE 20 MG/ML AT 6.5 MG/DAY, ALL PER CONTINUOUS INFUSION, INTRATHECALLY VIA THE SYNCHROMED II PUMP. ON (B)(6)2017, ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANAGING HEALTHCARE PROFESSIONAL (HCP) OFFICE THAT INDICATED THEY HAVE NEVER PRESCRIBED BACLOFEN TO THE PATIENT, AND PREFERRED TO NOT GIVE OUT FURTHER INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN WITH AN UNKNOWN DOSE AND CONCENTRATION, AND UNKNOWN DRUG WITH AN UNKNOWN DOSE AND CONCENTRATION, AND UNKNOWN MORPHINE WITH AN UNKNOWN DOSE AND CONCENTRATION VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THE PUMP WAS COMING CLOSER TO THE SURFACE, AND THE PATIENT WAS IN A LOT OF PAIN. THE PATIENT WAS TERRIFIED AFTER AN EVENT WHERE THEY WERE OVERDOSE, AND NOW WERE IN A POSITION TO CONSIDER GETTING THE PUMP REMOVED. EVENT DATE WAS NOTED AS 2014 (2-3 YEARS AGO). THE SITUATION WAS BEING ADDRESSED BY THE HEALTHCARE PROFESSIONAL. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617203 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR