BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYNCHROMED II

    MDR report key: 1180870 · Received September 23, 2008

    Report

    Report Number
    2182207-2008-06030
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT REFILL, A VOLUME DISCREPANCY WAS NOTED. THE PATIENT RETURNED TO CLINIC FOR A CHANGE IN TIMING OF A FLEX DOSE; HAS ALWAYS HAD "GOOD THERAPY". THE HCP ASPIRATED MORE VOLUME THAN EXPECTED. THE EXPECTED RESERVOIR VOLUME WAS 17 MLS; THE ACTUAL RESERVOIR VOLUME WAS 28 MLS. THE PATIENT HAS NOT NOTED ANY SYMPTOMS. THE PUMP CONTAINED DILAUDID 40 MG/ML AT 6.508 MG/DAY, FENTANYL 5 MG/ML AT 0.8135 MG/DAY, BUPIVICAINE 25 MG/ML AT 4.067 MG/DAY AND CLONIDINE 250 MCG/DML AT 40.67 MCG/DAY. ADDITIONAL INFO 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 ISYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709| IMPLANTED: