BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2402060 · Received January 6, 2012

    Report

    Report Number
    3007566237-2012-00044
    Event Type
    Injury
    Date Received
    January 6, 2012
    Report Date
    December 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LITERATURE: GAJEWSKI, J. B., AL-ZAHRANI, A. A. THE LONG-TERM EFFICACY OF SACRAL NEUROMODULATION IN THE MANAGEMENT OF INTRACTABLE CASES OF BLADDER PAIN SYNDROME: 14 YEARS OF EXPERIENCE IN ONE CENTRE. BJU INTERNATIONAL. 2011;107(8):1258-1264. DOI: 10.1111/J.1464-4 10X.2010.0969.7.X SUMMARY: THIS RETROSPECTIVE STUDY EVALUATED THE SUCCESS AND TOLERABILITY OF SACRAL NEUROMODULATION (SNM) IN THE CONTROL OF SYMPTOMS OF BLADDER PAIN SYNDROME IN PATIENTS WHO UNDERWENT PERIPHERAL NERVE EVALUATION (PNE) AND THEN SACRAL NERVE STIMULATION FROM 1994 TO 2008. SEVENTY-EIGHT PATIENTS UNDERWENT PNE AND 46 PATIENTS WENT ON TO PERMANENT IMPLANT. ALL PATIENTS HAD SYMPTOMS OF CHRONIC SUPRAPUBIC PAIN PERCEIVED TO BE RELATED TO THE URINARY BLADDER AND AT LEAST ONE OTHER LOWER URINARY SYMPTOM. PATIENTS WERE FOLLOWED AT 3, 6 AND 12 MONTHS AND YEARLY THEREAFTER. THE LONG-TERM SUCCESS RATE WAS 72% CAUSING THE AUTHORS TO CONCLUDE THAT SACRAL NERVE STIMULATION IS AN EFFECTIVE TREATMENT TO CONTROL SYMPTOMS OF BLADDER PAIN SYNDROME. REPORTED EVENTS: THREE PATIENTS UNDERWENT REMOVAL OF THE DEVICE DUE TO PAINFUL STIMULATION DESPITE SATISFACTORY OUTCOME WITH SNM. ONE PATIENT UNDERWENT REMOVAL OF THE DEVICE DUE TO RADIATION OF STIMULATION TO THE LEG DESPITE SATISFACTORY OUTCOME WITH SNM. TWELVE PATIENTS UNDERWENT REVISION DUE TO POOR OUTCOME OR DETERIORATION OF SYMPTOMS. MOST OF THESE PATIENTS REPORTED A FALL JUST BEFORE THE ALTERED STIMULATION. THREE PATIENTS UNDERWENT REVISION DUE TO PAINFUL STIMULATION. SIX PATIENTS UNDERWENT REVISION DUE TO IMPLANTED PULSE GENERATOR PAIN. THE PAIN BEGAN AFTER THE PATIENTS LOST WEIGHT. THREE PATIENTS UNDERWENT REVISION DUE TO RADIATION OF STIMULATION TO THE LEG. THERE WAS TECHNICAL DIFFICULTY IN NINE PATIENTS DURING THE PNE AND THE PNE COULD NOT BE COMPLETED. THE STIMULATION WAS LOST IN THREE PATIENTS DURING THE PNE AND THE PNE COULD NOT BE COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention