BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1181193 · Received September 30, 2008

    Report

    Report Number
    2182207-2008-06217
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PUMP STALLED AT 2312 IN 2008. THE PUMP WAS INTERROGATED TWO DAYS LATER; THE STALL WAS CONFIRMED WITH NO MOTOR STALL RECOVERY RECORDED. THERE WAS NO RECOVERY WITH 2-3 REINTERROGATIONS. THE PATIENT WAS EXPERIENCING INCREASED SPASTICITY. A PUMP ALARM WAS OCCURRING EVERY HOUR. THE PATIENT WAS AT THE CLINIC. THE PATIENT'S STATUS WAS REPORTED TO BE "FAIR". THE PATIENT'S SYMPTOMS CONTINUED TO WORSEN. THAT EVENING, THE PATIENT'S MOTHER CALLED 911 AND THE PATIENT WAS ADMITTED TO THE ICU AND STABILIZED. THE PUMP WAS REPLACED. THE PUMP WAS USED TO DELIVER BACLOFEN (2000 MCG/ML) AT A RATE OF 449.8 MCH/DAY. AS OF EIGHT DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AT HIS PREVIOUS DOSE OF APPROXIMATELY 450 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| L| R EXPLANTED| CATHETER MODEL 8731| PROGRAMMER MODEL 8840