BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201423 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00018
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    January 17, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. IT WAS A NON-CRITICAL ALARM DUE TO A LOW RESERVOIR VOLUME REACHED. THE PATIENT HAD BEEN AT ZERO VOLUME FOR OVER A MONTH. THE PATIENT WAS REFILLED AND REPROGRAMMED TO A LOWER DOSAGE. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THE EVENT. IT WAS UNKNOWN WHAT DRUG WAS BEING USED IN THE PUMP. 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
    301584 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1