BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRHOMED II

    MDR report key: 1083100 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04271
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN MRI AND A CONFIRMED MOTOR STALL OCCURRED; MOTOR STALL RECOVERY WAS NOT NOTED. A CRITICAL ALARM WAS NOT HEARD BUT WAS LATER CONFIRMED BY TELEMETRY. A STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGE ALSO APPEARED IN THE EVENT LOGS 48 HOURS AFTER THE MRI. RESERVOIR VOLUMES WERE CHECKED AND CONFIRMED ACCURACY. THE PATIENT WAS "CLINICALLY DOING WELL" WITH NO SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709SC LOT# N108657001| PROGRAMMER MODEL 8840 LOT# UNKNOWN