BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1192042 · Received October 7, 2008

    Report

    Report Number
    2182207-2008-06384
    Event Type
    Injury
    Date Received
    October 7, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED LEG WEAKNESS AND/OR SPASMS AND PAIN IN HER FEET. IT WAS ALSO REPORTED THAT HER ARMS WERE AFFECTED; THE SPECIFIC ARM SYMPTOMS WER NOT PROVIDED. THE CALLER STATED THAT THE PT HAD BEEN HOSPITALIZED 2 TIMES BECAUSE OF THIS. (SEE MANUFACTURER'S REPORT #2182207-2008-06383 FOR THE FIRST EVENT). THIS SECOND TIME, THE CALLER SAID HAPPENED ABOUT 2 WEEKS AFTER A REFILL. THE PT WAS HOSPITALIZED FOR 6 DAYS. AT THE HOSPITAL, THE CALLER STATED THAT THEY REMOVED ONE MEDICATION ("DOPENFALE" -AN ANTI NAUSEA MEDICATION) AND LEFT THE FENTANYL. THE HEALTH CARE PROFESSIONAL TOLD THE PT THE PUMP WAS WORKING FINE. THERE WERE NO PUMP ALARMS. THE PT WAS AT HOME. HER STATUS WAS REPORTED TO BE "FAIR". ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HEALTH CARE PROFESSIONAL, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 Hospitalization| R EXPLANTED| PROGRAMMER MODEL 8840| CATHETER MODEL 8709