BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1080195 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04225
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT. THE PATIENT'S SYMPTOMS INCLUDED DIZZINESS, INCREASED BASELINE SPASTICITY, VISUAL ISSUES, AND BRADYCARDIA. THIS OCCURRED DURING THE NORMAL REFILL CYCLE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND IT WAS UNKNOWN IF THERE WERE ANY ALARMS OR OTHER MEDICAL ISSUES. PUMP REPORTS WERE NOT OBTAINED AND IT WAS UNKNOWN IF THE PROGRAMMING AND INTRATHECAL DRUG PRESCRIPTION WERE CORRECT. THE PHYSICIAN TREATING THE PATIENT WAS NOT THE PATIENT'S MANAGING PHYSICIAN AND HE WAS NOT FAMILIAR WITH PUMP MANAGEMENT AND WAS UNSURE IF THE EVENTS WERE RELATED TO THE DEVICE. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| PROGRAMMER MDOEL 8840 LOT# UNKNOWN| EXPLANTED:| CATHETER MODEL 8709SC LOT# N115827005