BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202661 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00565
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    May 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZERO ML RESERVOIR VOLUME WAS REACHED. LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2012 AND CRITICAL EMPTY ALARM OCCURRED 14 DAYS LATER. ELEVEN DAYS LATER THE PUMP WAS FILLED WITH SALINE. THE PUMP WAS EXPECTED TO BE FILLED WITH DRUG 4 DAYS LATER, BUT REFILL HAS NOT BEEN CONFIRMED. THE DEVICE SYSTEM WAS USED TO DELIVER AN UNKNOWN DRUG AT THE TIME OF THE EMPTY RESERVOIR ALARM. NO PATIENT SYMPTOMS WERE 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
    302317 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR