BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1123823 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04992
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 16, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS NOT HAD GOOD THERAPEUTIC EFFECT; THE PUMP CONTAINED PRESERVATIVE-FREE MORPHINE. AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE LOG INDICATED THAT MULTIPLE MOTOR STALLS AND RECOVERIES HAVE OCCURRED.THE MOTOR STALLS HAVE LASTED LESS THAN TWO HOURS. RESIDUAL VOLUMES WERE NORMAL. THE PATIENT REPORTED THAT SHE USES AN ELECTRIC BLANKET THAT IS NOT TURNED ON. THE HCP PLANNED TO ATTEMPT TO IDENTIFY IF ELECTROMAGNETIC INTERFERENCE WAS AN ISSUE. A ROLLER STUDY WAS PERFORMED AND NO STALL WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL CATHETER| PROGRAMMER MODEL 8840| EXPLANTED: