BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1192043 · Received October 7, 2008

    Report

    Report Number
    2182207-2008-06383
    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. THE CALLER ALSO STATED THE PT'S 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 #2182207-2008-06384 FOR THE SECOND EVENT). THIS FIRST TIME, THE CALLER STATED THAT THEY FIGURED IT WAS DUE TO TROUBLE ACCESSING THE RESERVOIR PORT AND SOME OF THE MEDICATION LEAKED INTO THE SKIN AS IT HAPPENED QUICKLY AFTER THE REFILL. IT WAS UNCLEAR WHICH MEDICATION WAS BEING DELIVERED VIA THE PUMP DURING THIS EVENT. 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 CATHETER MODEL 8709| EXPLANTED| PROGRAMMER MODEL 8840