BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2890509 · Received November 30, 2012

    Report

    Report Number
    2890509
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    September 25, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    EZW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED INTERSTIM PART 1 PLACEMENT WITH FLUOROSCOPIC GUIDANCE OF NEEDLE POSITIONING WITHIN THE S3 FORAMEN. THE THIRD SACRAL NERVE WAS STIMULATED AT DIFFERENT ANGLES WITH DIFFERENT NERVE PLACEMENT, BOTH ON THE RIGHT AND THE LEFT. AT NO POINT DID THE PATIENT FEEL ANY STIMULATION OF EITHER NERVE ROOT, NOR DID THE PATIENT EXHIBIT ANY MOTOR STIMULATION. APPROXIMATELY A 45 MINUTE ATTEMPT IN DIFFERENT POSITIONS, ORIGINALLY THOUGHT THE PATIENT WAS NOT A CANDIDATE, PROCEDURE ABORTED. SURGEON AND REP PERFOMED AN INTERROGATION OF THE STIMULATING CORD, BECAUSE OF SUSPICIONS THAT THE CORD MAY NOT HAVE BEEN FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM SACRAL NEUROMODULATION EZW MEDTRONIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR