BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191211 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10923
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    September 29, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PATIENT CODE (B)(4) APPLIES TO THE PUMP. 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

    IT WAS REPORTED THAT THE PATIENT WAS OVERDOSING ON THE PUMP MEDICATION. IT WAS NOTED THAT THE PATIENT HAD BEEN REFILLED EARLIER THAT DAY. AT THE TIME OF REPORT, THE PATIENT WAS IN THE HOSPITAL AND THE HEALTHCARE PROFESSIONAL (HCP) WANTED TO TURN THE PUMP OFF. THAT SAME DAY, IT WAS REPORTED THAT THE PATIENT HAD BECOME UNRESPONSIVE WITHIN MINUTES FOLLOWING THE REFILL. IT WAS STATED THAT THE PATIENT HAD ALSO EXPERIENCED ALTERED MENTAL STATUS AND SWEATING. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE THE PUMP WAS REDUCED TO MINIMUM RATE, PER ORDER OF THE EMERGENCY ROOM PHYSICIAN, AND THE PATIENT WAS STARTED ON A NARCAN DRIP. IT WAS REPORTED THAT A POCKET FILL WAS SUSPECTED. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE, CLONIDINE, BUPIVACAINE, AND BACLOFEN. THREE DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS STILL IN THE HOSPITAL AND THE PUMP WAS STILL RUNNING AT MINIMUM RATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM CONSUMER ON (B)(6) 2017 REPORTED THE PATIENT HAD A STROKE. IT WAS NOTED THE REASON THE PATIENT HAD A STROKE WAS BECAUSE THERE WAS AN OVERDOSE DURING A REFILL PROCEDURE, AND THE STROKE WAS THE OUTCOME OF THE OVERDOSE. THE SITUATION WAS BEING ADDRESSED WITH THE HEALTHCARE PROFESSIONAL (HCP). NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    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 (B)(6)2002, AN ITREL 3 (MODEL NUMBER 7425 IMPLANTED ON (B)(6)2004-30). 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291136 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| O| R