BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1841838 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-07137
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    February 16, 2010
    Report Date
    February 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NEVER IMPLANTED. DURING REPLACEMENT SURGERY, LEADS WOULD NOT FIT ALL THE WAY INTO THE HEADER BLOCK. LEADS WERE SWITCHED AND STILL DID NOT FIT. A DIFFERENT IMPLANTABLE NEUROSTIMULATOR (INS) WAS TRIED AND THERE WERE NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1