BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3221225 · Received July 11, 2013

    Report

    Report Number
    9614453-2013-01476
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3023 (LOT # NBV641070S) SHOWED NO ANOMALY FOUND. FINAL ANALYSIS OF LEAD MODEL 3093 SHOWED LEAD BODY STRETCHED; NO SIGNIFICANT ANOMALY. FINAL ANALYSIS OF EXTENSION MODEL 3095-10 (LOT # NAH056716V) SHOWED NO ANOMALY FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID NEU_PTM_PROG, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093, LOT# UNKNOWN, IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION. (B)(4) - ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE DEVICE AND DEVICE COMPONENTS WERE EXPLANTED. IT WAS NOTED THEY WERE UNABLE TO PROPERLY SET UP DEVICE; A LOT OF PAIN AND ELECTRIC SHOCK TO THE PATIENT. REASON FOR REMOVAL WAS NOTED AS ELECTRIC SHOCKING PAIN AND UNABLE TO PROGRAM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND NEVER HAD THERAPEUTIC EFFECT SINCE IMPLANT. THE PATIENT THUS HAD A REVISION SURGERY TO REPLACE THE LEAD ¿LAST WEEK.¿ THE PATIENT WAS THEN REPROGRAMMED ON (B)(6) 2013 AND FELT STIMULATION FOR ¿ABOUT AN HOUR¿ BUT THEN STIMULATION STOPPED. THE PATIENT HAD NOT FELT STIMULATION ¿ALL WEEKEND¿ AND WAS NOT SEEING ANY THERAPY RELIEF. THE PATIENT¿S SYMPTOMS OCCURRED AT THE PERINEUM AND AT THE DEVICE LOCATION. THE PATIENT FELT A ¿FAINT PULSE¿ AT THE BATTERY DURING TESTING OF THE LEADS. THE PATIENT ¿ALWAYS¿ FELT STIMULATION FOR ¿ABOUT FOUR SECONDS¿ BEFORE IT FADED AND SHE STOPPED FEELING IT WITH EVERY PROGRAMMING CHANGE THAT WAS MADE DURING THE REPORT. THERE WAS NO SETTING WHERE THE STIMULATION STAYED THE WHOLE TIME. THE IMPEDANCE MEASUREMENTS WERE NORMAL AND MOTOR RESPONSE WAS VISIBLE IN THE OPERATING ROOM (OR). X-RAYS WERE TAKEN ¿LAST WEEK¿ AT THE POST-OP APPOINTMENT ON (B)(6) 2013. THE HEALTH CARE PROVIDER STATED THAT HE WAS ¿CERTAIN ON GOOD POSITION¿ AND GOOD MOTOR RESPONSE WAS SEEN ON ONE SIDE BUT NOT THE OTHER. DETAILED PROGRAMMING SETTINGS AND PATIENT RESPONSES WERE PROVIDED. THE SENSATIONS THE PATIENT FELT INCLUDED: A ¿FLICKERING¿ STIMULATION FOR ¿APPROXIMATELY FOUR SECONDS¿ THAT FADED AND STOPPED, A ¿SHARP¿ SENSATION, NO STIMULATION, STIMULATION AT BACK AND TAILBONE, ¿SLIGHT PULSING,¿ ¿FAINT¿ STIMULATION, ¿FLUTTERING¿ STIMULATION THAT FADED AWAY, ¿SHOCKING¿ SENSATION, STIMULATION IN THE BUTTOCK AND CHEEK AREA, A ¿HIGH INTENSE FLUTTER,¿ STIMULATION BEHIND THE RECTUM AND A ¿LITTLE PULSE¿ AT THE DEVICE SITE, AND ¿CRAZY, SPORADIC FLUTTERING.¿ THREE DAYS LATER IT WAS REPORTED THAT THE OUTCOME AND ACTION TAKEN BECAUSE OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319754 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention