BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4182794 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19953
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 26, 2014
    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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# VA0D0F3, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION ON THE DAY OF THE REPORT. THE PATIENT FELL IN (B)(6) AND THAT WAS THE REASON FOR THE LEAD REVISION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT CHANGED. THE ENTIRE LEAD WAS REMOVED. PRIOR TO THE REVISION THE PHYSICIAN ORDERED X-RAYS AND THE DEVICE WAS ALSO REPROGRAMMED. THE PATIENT FELT NO STIMULATION AT ALL ON ANY PROGRAM AS HIGH AS 8.5. FOLLOWING THE REPLACEMENT THE PATIENT WAS ABLE TO FEEL STIMULATION IN THEIR VAGINAL AREA AND IT WAS COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662239 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention