BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3071387 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01383
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED END OF SERVICE (EOS) WAS REACHED ON (B)(6) 2013. NEITHER THE PATIENT, NOR THE PATIENT'S NURSING HOME FACILITY, NOR THE HEALTH CARE PROVIDER (HCP) HEARD AN ALARM. IT WAS NOTED THAT IN 2011 THE ELECTIVE REPLACEMENT INDICATOR (ERI) SHOWED 12 MONTHS. THE PUMP WAS READ ON (B)(6) 2012, BUT THERE WAS NO RECORD AVAILABLE OF WHAT WAS READ. IT WAS NOTED THE PATIENT DID NOT EXPERIENCE WITHDRAWAL, BUT WAS TAKING ORAL BACLOFEN FOR UPPER EXTREMITY SPASTICITY. THE PUMP WAS BEING USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171290 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR