BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1091583 · Received August 1, 2008

    Report

    Report Number
    2182207-2008-04571
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S PUMP HAD LESS VOLUME THAN EXPECTED AT REFILL. THE EXPECTED RESERVOIR VOLUME WAS 8 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 0 ML. THE PUMP HAD BEEN HAVING VOLUME DISCREPANCY ISSUES OVER THE LAST 4 TO 6 MONTHS. THE PT REPORTEDLY WENT THROUGH A WITHDRAWAL EPISODE AND RENAL FAILURE. THE DRUG USED IN THE PUMP WAS NOT REPORTED. IT WAS NOT CONSIDERED LIKELY THE PUMP RESERVOIR WAS BEING ACCESSED. NO AUDIBLE ALARMS WERE NOTED. NO ERROR MESSAGES WERE NOTED ON PUMP STATUS REPORTS OR IN THE EVENT LOG. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| CATHETER MODEL 8731 LOT# N003240527| PROGRAMMER MODEL 8840 LOT# UNKNOWN