BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3132493 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-04755
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J11339R25, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. HEALTH CARE PROFESSIONAL REPORTED A BROKEN PROGRAMMER SYMBOL WHEN INTERROGATING/UPDATING THE PATIENT¿S PUMP. PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS (NAUSEA, VOMITING, CLAMMY, AND SNEEZING). HCP INDICATED THERE WERE NO ISSUES NOTED IN THE LOGS. PATIENT WAS LAST FILLED (B)(6) 2012. HCP RE-INTERROGATED WITH ANOTHER PROGRAMMER AND SAW THAT THE PUMP HAD BEEN IN STOPPED MODE FOR 10 MIN. HCP THEN REPROGRAMMED THE PUMP TO THE PATIENT¿S NORMAL PROGRAMMED RATE. HCP WAS GOING TO TRY TO PERFORM A CATHETER DYE STUDY BUT WAS NOT ABLE TO ACCESS THE PORT. HCP WAS GOING TO HAVE A DYE STUDY PERFORMED UNDER FLUOROSCOPY. SYSTEM USED TO DELIVER BUPIVACAINE AND DILAUDID (HYDROMORPHONE). HCP LATER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN . REPORTED IT WAS UNKNOWN IF THE ISSUES WERE DUE TO THE PUMP OR CATHETER. PATIENT SYMPTOMS WERE RESOLVED AFTER ORAL DILAUDID AND ZOFRAN. REPORTED POSSIBLE VIRAL INFECTION AND SYMPTOMS NOT RELATED TO THE PUMP FOLLOW UP INFORMATION HAS BEEN REQUESTED BUT NO ADDITIONAL INFORMATION HAD BEEN PROVIDED AS OF THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT FOLLOWING IMPLANT IN (B)(6) 2012, THE PATIENT COMPLAINED OF ¿NO RELIEF¿ AND ¿SEVERE¿ WITHDRAWAL SYMPTOMS. MEDICATION WEANING BEGAN (B)(6) 2012 AND ON (B)(6) 2013, THE PUMP WAS DELIVERING NORMAL SALINE. REPORTEDLY, THE PHYSICIAN QUESTIONED WHETHER OR NOT THERE WAS A POSSIBLE CATHETER LEAK. HOWEVER, ON (B)(6) 2013, AN INDIUM STUDY WAS DONE WHICH SHOWED NO LEAKAGE FROM THE PUMP OR CATHETER. THE PATIENT NOTICED A ¿5%¿ IMPROVEMENT. THE PATIENT WAS RECEIVING BI-WEEKLY INCREASED DOSAGES UNTIL THE GOAL WAS REACHED. AS OF (B)(6) 2013, THE PUMP WAS DELIVERING HYDROMORPHONE, 2.0 MG/ML @ 0.6431 MG/DAY. THE PATIENT OUTCOME WAS REPORTED AS ¿RECOVERED WITHOUT SEQUELA¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234171 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR