BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1083213 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04322
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER FEELING THE STIMULATION AT THE SITE OF THE SACRUM (WHERE THE LEAD BENDS CHANGING DIRECTION TOWARDS THE SNM), THE PATIENT WAS NO LONGER FEELING STIMULATION. ALL THE LEAD IMPEDANCE MEASUREMENTS WERE GREATER THAN 4,000 OHMS. THE LEAD WAS REPLACED. FURTHER INFORMATION IS BEING REQUESTED FROM THE MDT REP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL# 3093 LOT# UNKNOWN IMPLANTED| EXPLANTED