BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE INFUSION SET

    MDR report key: 455953 · Received April 22, 2003

    Report

    Report Number
    MW1028214
    Event Type
    Malfunction
    Date Received
    April 22, 2003
    Date of Event
    March 13, 2003
    Report Date
    April 17, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER WAS USING THE MEDTRONIC MINIMED INSULIN PUMP #508 FOR ADMINISTRATION OF NOVOLG INSULIN. THE CONSUMER WAS COMPLETING A ROUTINE CHANGE OF THE SILHOUETTE INFUSION SET, & WHEN REMOVING THE DEVICE (INSERTION SITE IN ABDOMEN), THE CATHETER (MICRO-TUBE), REMAINED INSIDE THEIR SKIN. THE MICRO-TUBE IS ONE INCH IN LENGTH. THE EVENT OCCURRED IN 2003 & THEY SPOKE TO THEIR ENDROCINOLOGIST 5 DAYS LATER DUE TO DISCOMFORT AT THE INSERTION SITE. THE CONSUMER DESCRIBES THE DISCOMFORT AS FEELING LIKE THE MICRO-TUBE IS, "HITTING A NERVE". 2 DAYS LATER, THE CONSUMER WAS SEEN BY A SURGEON & 4 DAYS LATER THE SURGEON ATTEMPTED TO REMOVE THE MICRO-TUBE IN SURGEON'S OFFICE WITHOUT SUCCESS. HOWEVER, THE SURGEON DID REMOVE SCAR TISSUE. THE INCISION REQUIRED SUTURES TO CLOSE. THE SURGEON BELIEVES THE MICRO-TUBE MIGRATED DOWNWARD. THE INCISION IS HEALING. AT THIS TIME, THE DECISION WAS MADE NOT TO ATTEMPT FURTHER PROCEDURES TO REMOVE THE MICRO-TUBE, BUT TO WAIT & SEE IF THE CONSUMER DEVELOPS ADDITIONAL PROBLEMS. THE CUSTOMER CALLED THE MEDTRONIC CO USING THE 24 HR TOLL FREE NUMBER (1-800-826-2009) & REPORTS MEDTRONIC WAS NOT INTERESTED IN THEIR COMPLAINT, BUT DID OFFER TO REPLACE THE ONE SILHOUETTE INFUSION SET. REPORTS THAT THEY HAVE NOT EXPERIENCED ANY PROBLEMS WITH THE OTHER SILHOUETTE INFUSION SETS CONTAINING THE SAME SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE INFUSION SET USED WITH MINIMED INSULIN PUMP #508 FPA MEDTRONIC MINIMED * 531118

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other MINIMED INSULIN PUMP #508.