BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAL ANCHOR

    MDR report key: 908505 · Received March 14, 2007

    Report

    Report Number
    2182207-2007-00877
    Event Type
    Malfunction
    Date Received
    March 14, 2007
    Report Date
    February 14, 2007
    Manufacturer
    MEDTRONIC, INC. NEUROLOGICAL DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A PISCES QUAD LEAD USING THE TITAN ANCHOR. SEVERAL DAYS AFTER IMPLANTATION, THE PATIENT DIDN'T FEEL PARESTHESIA IN THE CORRECT AREA ANYMORE. UPON FURTHER INVESTIGATION, THE PHYSICIAN FOUND THE TITAN ANCHOR AND THE LEAD HAD MOVED FROM THEIR INITIAL LOCATION, SO THE PHYSICIAN DECIDED TO REPLACE THE LEAD SYSTEM WITH A SURGICAL LEAD. DURING SURGERY, THE PHYSICIAN DISCOVERED THE TITAN ANCHOR HAD SEPARATED INTO TWO SECTIONS: THE EXTERNAL SILICONE WAS STILL AT ITS ORIGINAL PLACE, BUT, THE METALKIC INSERT HAD MOVED WITH THE LEAD. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAL ANCHOR LGW LGW MEDTRONIC, INC. NEUROLOGICAL DIVISION 3550-39 N091832

    Patients

    Seq Age Sex Outcome Treatment
    1 YR