BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERSTIM

    MDR report key: 795108 · Received December 8, 2006

    Report

    Report Number
    3004209178-2006-02171
    Event Type
    Other
    Date Received
    December 8, 2006
    Report Date
    November 7, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL
    Product Code
    EZW
    PMA / PMN Number
    p970004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC INC. FOR EVALUATION. IF FURTHER INFORMATION IS RECEIVED, OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MEDTRONIC REPRESENTATIVE THAT THE DEVICE SYSTEM WAS REMOVED DUE TO AN INFECTION. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE HCP BUT IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SENT IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW EZW MEDTRONIC PUERTO RICO OPERATIONS CO., MEDREL 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention EXTENSION MODEL 3095, LOT# NAH032673V, IMPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3889, LOT# V011742, IMPLANTED