BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1172116 · Received September 18, 2008

    Report

    Report Number
    3004209178-2008-05897
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    May 28, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A REFILL THERE WAS A VOLUME DISCREPANCY GREATER THAN 25%. THE EXPECTED RESERVOIR VOLUME WAS 2.6CC, THE ACTUAL RESERVOIR VOLUME WAS 25CC. IT WAS FELT THERE MAY HAVE BEEN AN INPUT ERROR, SO THE DECISION WAS MADE TO WAIT UNTIL THE NEXT REFILL TO SEE IF THERE WAS A CONTINUED VOLUME DISCREPANCY. AT THE NEXT REFILL, THE EXPECTED RESERVOIR VOLUME WAS 21.3CC, THE ACTUAL RESERVOIR VOLUME WAS 35CC, WHICH WAS WITHIN THE MANUFACTURER'S ACCEPTABLE VARIANCE OF 25%. THE PHYSICIAN DECIDED TO DO FURTHER TROUBLESHOOTING. IT WAS DETERMINED THAT THE CATHETER WAS PATENT. THE PATIENT'S FLOW RATE WAS INCREASED TO SEE IF THIS RESOLVED THE ISSUE. NO PATIENT SYMPTOMS OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR CATHETER: MODEL 8703W| IMPLANTED:| EXPLANTED:| PRGRAMMER: MODEL 8840