BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3890157 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11954
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 3, 2014
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID: 8 598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    WITHDRAWAL WAS REPORTED. THE REPORTER STATED THE PATIENT WAS IN THE HOSPITAL OVER THE WEEKEND OF (B)(6) 2014. THEY NOTED THAT FRIDAY INTO SATURDAY, THE REPORTER BELIEVED THE PUMP ¿SPIKED¿ AND THE PATIENT ¿WENT NUTS¿. IT WAS ALSO NOTED THE PATIENT WAS IN THE HOSPITAL ON A ¿MARCAINE DRIP¿ AND THE PUMP WAS DECREASED 75 PERCENT. THE REPORTER ALSO NOTED THE PATIENT HAD BEEN THROWING UP, SWEATING, ¿(B)(6)¿, AND HAD BEEN UP A ¿COUPLE NIGHTS HURTING (B)(6)". THE REPORTER QUESTIONED IF THE ISSUE COULD HAVE BEEN DUE TO THE PATIENT HAVING AN OLD PALM PILOT ON THEIR STOMACH AND THEN SWITCHING INFORMATION FROM THE PALM PILOT TO THE COMPUTER. THE REPORTER WAS REDIRECTED TO THE PATIENT¿S HEALTH CARE PROVIDER (HCP). THE REPORTER STATED THE MEDICATION DOSAGE AND CONCENTRATION WERE WORKING GREAT UNTIL THE PATIENT ¿WENT LUNATIC¿ AND TRIED TO ESCAPE THE HOSPITAL AND RAN AROUND IT SEARCHING FOR CHEWING TOBACCO PLANTS. THE REPORTER STATED THEY KNEW THE MORPHINE WAS ¿SPIKING¿. THEN THEY NOTED THEY ¿HAD A NEW IV GOING WHEN I WENT BACK IN THE HOSPITAL AND IT SEEMED LIKE IT WENT UP MORE". THE PUMP WAS CURRENTLY BEING USED TO DELIVER CLONIDINE AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368291 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Hospitalization