BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190378 · Received July 25, 2011

    Report

    Report Number
    3007566237-2011-05748
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT PRESENTED IN ER WITH "ABSTINENCE SYMPTOMS". ON INTERROGATION THE PUMP SHOWED A "ROTOR STALL OCCURRED" MESSAGE. PT ALSO HEARD THE CRITICAL ALARM. THE PUMP HAD AN ELECTIVE REPLACEMENT INDICATOR (ERI) OF 10 MONTHS. PHYSICIAN TRIED TO RESTART THE PUMP, BUT FAILED. PT WAS ADMITTED IN THE HOSPITAL TOP COMPENSATE THE ABSTINENCE SYMPTOMS. THE PUMP WAS TO BE REPLACED. ON (B)(6) 2011, IT WAS REPORTED THAT THE PT WAS NOW DOING FINE: WITHDRAWAL SYMPTOMS HAD DISAPPEARED; ADEQUATE PAIN RELIEF WAS REGAINED USING THE NEW PUMP.

    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