BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1133116 · Received August 22, 2008

    Report

    Report Number
    2182207-2008-05190
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT MISSED A REFILL DUE TO THE ALARM NOT BEING HEARD. TELEMETRY DID CONFIRM A NON-CRITICAL ALARM HAD OCCURRED IN 2008, DUE TO LOW RESERVOIR VOLUME REACHED AS WELL AS CRITICAL ALARM ONE WEEK LATER, DUE TO ZERO ML RESERVOIR VOLUME HAD BEEN REACHED. THE MANUFACTURER'S REPRESENTATIVE CONFIRMED THAT THE ALARM INTERVALS WERE BOTH SET. THE HCP PROGRAMMED BOTH CRITICAL AND NON-CRITICAL ALARMS AND BOTH WERE HEARD BY THE HCP, MANUFACTURER'S REPRESENTATIVE AND THE PATIENT'S FAMILY. NO PATIENT SYMPTOMS WERE REPORTED AS A RESULT OF THE MISSED REFILL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| CATHETER: MODEL CATHETER| IMPLANTED: