BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAUSSE LARGE LOOP PISTON

    MDR report key: 1290901 · Received December 5, 2008

    Report

    Report Number
    1045254-2008-00041
    Event Type
    Other
    Date Received
    December 5, 2008
    Date of Event
    October 24, 2008
    Report Date
    December 5, 2008
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    FZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WERE NOT SUCCESSFUL. THE PRODUCT WAS UNAVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE PERFORMANCE OF THE REPORTED DEVICE WAS NOT POSSIBLE. THERE IS NO INVENTORY REMAINING OF THE REPORTED LOT NUMBER. THE DEVICE HISTORY RECORDS WERE REVIEWED. NO ISSUES, NO ANOMALIES FOUND ON THIS PRODUCT AND LOT. A SIMILAR FLUOROPLASTIC PISTON WAS EVALUATED AND MATERIAL MET THE PRODUCT SPECIFICATION. REFERENCE MDR# 1045254-2008-00040 FOR PATIENT EVENT 1 OF 2.

    Description of Event or Problem · 1

    A MEDTRONIC EMPLOYEE WAS NOTIFIED OF AN INCIDENT BY A PHARMACIST FROM HOSPITAL IN A FOREIGN COUNTRY, THE DOCTOR STATES THAT HE HAD TO REVISE A CASE OF OTOSCLEROSIS BECAUSE THE FLUOROPLASTIC LOOP MATERIAL OF THE PISTON IMPLANT, WHICH SHOULD HAVE SHAPE MEMORY, OPENED UP AGAIN. SURGEON STATES THAT THIS IS THE SECOND CASE THIS WEEK WITH THE SAME LOT NUMBER. THE FACILITY INDICATED THAT THERE WAS NO PATIENT INJURY. NOTE: THIS MDR IS FOR CASE 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUSSE LARGE LOOP PISTON PROSTHESIS, EAR, INTERNAL FZD MEDTRONIC XOMED, INC. 1156241 54501600

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention