BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3070793 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01376
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP ALARM WAS HEARD. UPON INTERROGATION, THERE WERE MULTIPLE MOTOR STALLS AND MOTOR STALL RECOVERIES THAT WERE RECORDED IN EVENT LOGS BEGINNING IN (B)(6) 2013. ON (B)(6) 2013 A STALL OCCURRED AND RECOVERED 5 MINUTES LATER. ON (B)(6) A STALL OCCURRED AT 7:36 AND RECOVERED THE SAME DAY AT 7:57. IT WAS NOTED THAT THE STALLS WERE OCCURRING APPROXIMATELY EVERY HOUR ON THE HOUR. THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE SYMPTOMS AT THAT TIME. THE PUMP SYSTEM WAS DELIVERING HYDROMORPHONE AND BUPIVACAINE. 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
    171205 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1