BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3833208 · Received May 27, 2014

    Report

    Report Number
    3007566237-2014-01437
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT WAS IN A LOT OF PAIN AND WAS NOT SURE IF IT WAS WORKING. THE PATIENT¿S PAIN HAD BEEN PROGRESSING THE PAST 5-6 MONTHS. THE PATIENT NEEDED HIS HEALTH CARE PROVIDER (HCP) TO FILL OUT A PRESCRIPTION FOR PAIN. AT THE TIME OF THE REPORT IT WAS NOTED THE SYSTEM WAS BEING USED TO DELIVER MORPHINE AND AN UNKNOWN SECOND DRUG. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN HAVING INCREASED PAIN AND A RETURN OF SYMPTOMS. THE PAIN WAS INCREASING FOR THE LAST MONTH AND HIS CONDITION MAY HAVE BEEN GETTING WORSE. THE PATIENT WAS DUE FOR A REFILL ON (B)(6) AND WAS LAST REFILLED (B)(6). THE SYSTEM WAS BEING USED TO DELIVER BUPIVACAINE AND MORPHINE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311637 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR