BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1180990 · Received September 29, 2008

    Report

    Report Number
    2182207-2008-06197
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED WHILE UPDATING A RECENTLY IMPLANTED PUMP. AN ALARM TEST WAS PERFORMED FOR THE PATIENT AND THE CRITICAL ALARM INTERVAL WAS DECREASED TO 10 MINUTES. WHEN THE PUMP WAS UPDATED, A MOTOR STALL MESSAGE WAS NOTED. THE PUMP WAS INTERROGATED MULTIPLE TIMES WITH MULTIPLE PROGRAMMERS, AND EACH TIME WHEN THEY READ THE PUMP THEY RECEIVED A MOTOR STALL MESSAGE. THERE WERE NO LOGS THAT SHOWED A MOTOR STALL AND THEY DID NOT HEAR THE AUDIBLE ALARM. THE HCP WAS CONSIDERING MONITORING THE PATIENT TO DETERMINE IF THE PUMP WAS ACTUALLY STALLED. NO PATIENT SYMPTOMS WERE REPORTED. 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| IMPLANTED:| EXPLANTED: