BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1083101 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04364
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 26, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A RETURN OF SYMPTOMS AND THAT THERE WAS A VOLUME DISCREPANCY; EXPECTED RESERVOIR VOLUME WAS 2.8 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 18 ML. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WERE NOT REPORTED. IT WAS LATER REPORTED THAT THE PT MISSED A REFILL IN 2008, YET THE PUMP HAD BEEN RUNNING ON A SIMPLE CONTINUOUS MODE. THE PT'S PHYSICIAN PERFORMED A DYE STUDY LATER, AND IT WAS DETERMINED THAT THE CATHETER WAS NOT PATENT. A CATHETER REVISION WAS PLANNED. THE PT WAS CONCERNED REGARDING THE PUMP FUNCTION.

    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 66 YR Required Intervention PROGRAMMER MODEL 8840 LOT#UNK| CATHETER MODEL #: 8731SC| IMPLANTED:| EXPLANTED: