BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4484023 · Received February 4, 2015

    Report

    Report Number
    3004209178-2015-01730
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    August 1, 2013
    Report Date
    January 12, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V890309, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LACK OF EFFICACY AND HAD TURNED THEIR DEVICE OFF IN (B)(6). THE PATIENT DID NOT WANT THE DEVICE REPLACED. INTERVENTION INVOLVED EXPLANTING THE ENTIRE SYSTEM. THE ETIOLOGY WAS DUE TO THE PROGRAMMING AND WAS NOTED AS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82665 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention