BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3241227 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02430
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS REPLACED AS THERE WAS NO MORE BENEFIT FROM THERAPY. THE REVISION WAS COMPLETED ON (B)(6) 2013 AS THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. THE HEALTH CARE PROVIDER (HCP) HAD PERFORMED CONTRAST STUDIES AND INDIUM SCAN, BOTH OF WHICH WERE COMPLETELY NORMAL. THERE WERE NO ABNORMALITIES IN THE PUMP LOGS, AND THERE WAS ALWAYS ¿SOMEWHAT MORE¿ OF AN ACTUAL RESIDUAL VOLUME THAN THE EXPECTED RESIDUAL VOLUME, BUT THEY WERE WITHIN NORMAL LIMITS. THE ROTOR TEST PERFORMED WAS ALSO NORMAL. FOLLOWING THE REVISION THE PATIENT HAD BETTER EFFECT AND LESS USE OF ORAL MEDICATIONS, BUT NOT YET COMPLETE CONTROL OF SPASTICITY. THE PUMP DEVICE WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341850 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN NERUO CATHETER