BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092417 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01523
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ATTORNEY ALLEGES THAT IN LATE SUMMER OF 2012, THE PATIENT BEGAN TO EXPERIENCE EXTREME AND CONTINUOUS PAIN, NAUSEA, DIARRHEA, DEPRESSION, ANXIETY ATTACKS, SUICIDAL THOUGHTS, WITHDRAWAL AND OTHER MEDICAL PROBLEMS. REPORTEDLY, THESE PROBLEMS HAD PERSISTED UNTIL IT HAD BEEN DISCOVERED THAT THE DEVICE WAS "DEFECTIVE" AND HAD NOT BEEN OPERATING; DEPRIVED MORPHINE TO THE PATIENT. NO WARNING WAS EMITTED FROM THE DEVICE INDICATING ITS "FAILURE," REPORTEDLY. A NEW PUMP WAS THEREFORE IMPLANTED. THIS DEVICE SYSTEM DELIVERED MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194968 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention