BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5132106 · Received October 7, 2015

    Report

    Report Number
    3004209178-2015-20143
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    February 1, 2014
    Report Date
    December 6, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# V241707, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND THAT THE DEVICE WAS NOT WORKING AS WELL AS BEFORE. THE PATIENT HAD FREQUENCY, URGENCY, INCREASED NOCTURIA, AND INCOMPLETE BLADDER EMPTYING. INTERVENTION INVOLVED REPROGRAMMING AND MEDICATION ADJUSTMENT. THE ETIOLOGY WAS NOTED AS RELATED TO THE PROGRAMMING. THE EVENT WAS ONGOING AND POSSIBLE RELATED TO DEVICE OR THERAPY AND UNLIKELY RELATED TO THE IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON JULY 7, 2014 REPORTED THAT THERE WAS NO IMPROVEMENT IN THE BLADDER. IT WAS NOTED THAT INTERVENTIONS INCLUDED REPROGRAMMING AND OXYBUTYNINE 10MG DAILY ON (B)(6) 2014. FURTHER INFORMATION RECEIVED ON JULY 31, 2014 REPORTED THAT INTERVENTIONS INCLUDED CLEAN INTERMITTENT SELF-CATHETERIZATION (CIC) 2-3 TIMES A DAY. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED AS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER FOR A CLINICAL STUDY REPORTED THE ENTIRE SYSTEM WAS EXPLANTED AND THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. INDICATIONS FOR USE INCLUDE GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663382 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention