BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4612217 · Received March 18, 2015

    Report

    Report Number
    3004209178-2015-04909
    Event Type
    Injury
    Date Received
    March 18, 2015
    Report Date
    February 5, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37092, LOT# 317380001, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3 889-28, LOT# V942569, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF DEVICE EFFICACY. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. INTERVENTIONS INCLUDED THERAPY SUSPENDED. NO DIAGNOSTIC METHODS WERE USED. THE SUBJECT TURNED THE DEVICE OFF ON (B)(6) 2013 DUE TO DECIDING IT WAS NO LONGER WORKING FOR HER. THE PATIENT WANTED IT EXPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED ETIOLOGY INCLUDED IT WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE ENTIRE SYSTEM WAS EXPLANTED AND THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184656 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention