BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1102603 · Received August 8, 2008

    Report

    Report Number
    3004209178-2008-04804
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT STIMULATION. THE LEAD IMPEDANCE MEASUREMENTS WERE IN THE 2500 OHMS RANGE. THE LEAD WAS FRACTURED, POSSIBLY AT DISSECTION. THE WHOLE SYSTEM WAS EXPLANTED. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention EXPLANTED| EXPLANTED| LEAD MODEL 3889| EXTENSION MODEL 3095