BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1378431 · Received May 8, 2009

    Report

    Report Number
    2182207-2009-03301
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 10, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED SWELLING, RASH, AND CRACKING OVER HER ENTIRE BODY FOR SEVERAL WEEKS AFTER HER CATHETER WAS REPLACED. (SEE MFR REPORT # 2182007-2009-03305). A FINGER WAS ALSO BRAKING OUT IN SORES. ONE FOOT WAS "PURPLE". AN ALLERGY TEST WAS PERFORMED AND FOUND THE PT WAS ALLERGIC TO THE SILICONE IN THE TUBING AND THE PORT. THE PT HAD PLANNED TO SEE AN ALLERGIST FOR TREATMENT, THE SYSTEM WILL BE EXPLANTED.

    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 40 YR Required Intervention CATHETER: MODEL 8596SC| CATHETER: MODEL 8598A| EXPLANTED:| PROGRAMMER: MODEL 8840| EXPLANTED: