BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5035203 · Received August 27, 2015

    Report

    Report Number
    3004209178-2015-16835
    Event Type
    Injury
    Date Received
    August 27, 2015
    Report Date
    August 3, 2015
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED ON (B)(6) 2015 FROM A CONSUMER VIA CRTS (CUSTOMER RESPONSE TRACKING SYSTEM) REGARDING A MALE 61 YEAR OLD PATIENT RECEIVING MORPHINE (UNKNOWN) VIA AN IMPLANTED INFUSION PUMP. THE INDICATION FOR USE WAS NOTED AS NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. THE CONSUMER REPORTED THAT HE HAD BEEN GOING TO HIS HEALTHCARE PROVIDER (HCP) FOR TWO MONTHS AND THE MEDICATION HAD BEEN TITRATED DOWN SLOWLY. IN (B)(6) 2015 THE PUMP STARTED TO ALARM. THE CONSUMER WAS IN THE HOSPITAL BEING TREATED FOR WITHDRAWALS. HE STATED HE WAS FEELING OUT OF SORTS AND EDGY, AND HE FELT LIKE HE HAD THE GEE BEE GEE BEES. THE CONSUMER REPORTEDLY HAD DIARRHEA, NAUSEA, AND HIS BLOOD PRESSURE SHOT UP. THE CONSUMER WAS BEING TREATED WITH A CATAPRES (CLONIDINE) TTS (TRANSDERMAL) 0.1MG PATCH TO HELP WITH WITHDRAWAL SYMPTOMS. THE NAUSEA WAS TREATED WITH ONDANESTRON. SALINE WAS TO BE PUT IN THE PUMP NEXT WEEK AT AN APPOINTMENT WITH THE MANAGING HCP. THE CONSUMER MENTIONED THAT THE ALARM WAS NOT AS LOUD AS IT USED TO BE. AS OF (B)(6) 2015 ALL SYMPTOMS HAVE BEEN RESOLVED, PER THE CONSUMER, AND THERE WERE NO DEVICE CONCERNS. THE BLOOD PRESSURE SPIKE WAS DUE TO WITHDRAWAL, AND THE PATIENT HAD BEEN ADMINISTERED AMLODIPINE 5MG (1 DAILY), LOSARTAN POTASSIUM 100MG (1 AT BEDTIME). THE BLOOD PRESSURE ISSUES STOPPED ON (B)(6) 2015. THE CONSUMER WAS CURRENTLY TAKING BENICAR HCT ONCE DAILY. THE ALARM WAS TO BE DISABLED AT AN HCP APPOINTMENT (B)(6) 2015 AND ANY REMAINING MORPHINE IN THE PUMP WOULD BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567353 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization