BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4180538 · Received October 17, 2014

    Report

    Report Number
    3007566237-2014-03016
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD REPORTED A VOLUME DISCREPANCY ON AN UNSPECIFIED PUMP. NO PATIENT SYMPTOMS WERE REPORTED AND IT WAS UNKNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY EVENT DETAILS, MEDICATIONS DELIVERED, AND PATIENT STATUS. HOWEVER, THIS INFORMATION WAS NOT AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THE HEALTHCARE PROFESSIONAL (HCP) DISCOVERED A VOLUME DISCREPANCY UP TO 3 ML DURING THE REFILL PROCESS. NO PATIENT SYMPTOMS REPORTED, NO DEVICE INFORMATION WAS REPORTED AND NO MEDICATION INFORMATION WAS REPORTED. ADDITIONAL FOLLOW-UP HAS BEEN ATTEMPTED FOR THE MISSING INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663273 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1