BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5748586 · Received June 24, 2016

    Report

    Report Number
    3004209178-2016-12872
    Event Type
    Injury
    Date Received
    June 24, 2016
    Date of Event
    April 1, 2016
    Report Date
    June 24, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THE PATIENT HAD POOR COMMUNICATION, AND NEITHER THE PATIENT PROGRAMMER (PP) OR PHYSICIAN PROGRAMMER (PHP) WOULD COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS GETTING A RETURN OF SYMPTOMS SINCE (B)(6), IT TOOK THEM A WHILE TO REALIZE THE RETURN OF SYMPTOMS MAY BE RELATED TO THE DEVICE AND THEY HAD REALIZED THE SYSTEM WASN'T WORKING. THE HCP NOTED THE PATIENT HAD NOT BEEN IN THE OFFICE FOR TWO YEARS AND WOULD LEAVE A MESSAGE FOR A MANUFACTURER REPRESENTATIVE (REP) TO SCHEDULE TIME FOR SURGERY TO REPLACE THE INS. THE INS WAS IMPLANTED (B)(6) 2011 AND THERE WERE NO COMPLAINTS OF EARLY BATTERY DEPLETION WITH AN IMPLANT THAT WAS GREATER THAN FIVE YEARS OLD. THE HCP LATER REPORTED THE BATTERY WAS NOT WORKING AFTER HAVING CHECKED THE DEVICE ON TWO OCCASIONS WITH THREE SUCCESSFUL COMMUNICATIONS. IT WAS NOTED THE HCP HAD DISCUSSED THE ISSUE WITH THE MANUFACTURER CLINICAL SPECIALIST TWICE. THE ISSUE HAD NOT BEEN RESOLVED, HOWEVER THEY WERE GOING TO REPLACE THE BATTERY AND/OR LEADS ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401831 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention