BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6054807 · Received October 25, 2016

    Report

    Report Number
    3004209178-2016-22487
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 25, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WITH AN IMPLANTABLE DRUG INFUSION PUMP INDICATED FOR SPINAL PAIN. THE PUMP CONTAINED FENTANYL AND BUPIVACAINE AT UNKNOWN CONCENTRATION AND DOSES. IT WAS REPORTED THE PUMP WAS ALARMING OR BEEPING. THE PATIENT REPORTED HEARING A TRUCK BACKING UP AS A DESCRIPTION OF THE ALARM/BEEPING. THE SOUND WAS CONSISTENT WITH PUMP ALARMS. THE PATIENT MENTIONED THE ALARM EVENT COULD HAVE BEEN RELATED TO THE MISSED SCHEDULED REFILL. THE PATIENT STATED THE PUMP WAS SUPPOSED TO BE FILLED ON (B)(6) 2016 FOR THE FIRST TIME. THE PATIENT STATED SHE HAD AN APPOINTMENT ON (B)(6) 2016. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT STATED THAT THE PUMP HAD NOT BEEN REFILLED SINCE IMPLANT. THE PATIENT WAS ALREADY UPSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705520 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR