BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061961 · Received April 5, 2011

    Report

    Report Number
    3007566237-2011-02582
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT EXPERIENCED INCREASED BASELINE SPASTICITY IN LEGS DURING THE EVENING HOURS. THE HCP WAS REPROGRAMMING THE PUMP TO DELIVER FLEX DOSING WITH ADDITIONAL MEDICATION DELIVERY DURING THE EVENING HOURS. IT WAS LATER REPORTED THE HCP EXPECTED 6.8 ML TO BE WITHDRAWN FROM PUMP, BUT WAS UNABLE TO WITHDRAW ANY MEDICATION. THEREFORE, THE HCP DID NOT FEEL LIKE THE CENTER PORT WAS ACCESSED. ATTEMPTS AT ACCESS WERE MADE ON (B)(6) 2011 WITHOUT SUCCESS. THE PUMP WAS ABOUT "AN INCH DEEP." THERE WAS A DEPTH ISSUE. THE PUMP CONTAINED LIORESAL 500 MCG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IMPLANTED:| CATHETER: MOEDL 8709SC, LOT# N216456031| EXPLANTED: