BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4996292 · Received August 12, 2015

    Report

    Report Number
    3004209178-2015-15870
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# V001785, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURING REPRESENTATIVE REPORTED THAT THE PATIENT WAS CONSIDERED A POTENTIAL REPLACEMENT PATIENT. THE PATIENT DID NOT BELIEVE THE DEVICE WAS WORKING FOR HER ANYMORE. NO INTERVENTIONS OR OUTCOMES WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA THE PATIENT REPORTED THAT SHE DIDN'T REALLY USE THE DEVICE BECAUSE, IT DOESN'T REALLY WORK. THE PATIENT WAS NOT INTERESTED IN MAKING AN APPOINTMENT BECAUSE SHE WANTED TO TALK TO A FAMILY MEMBER BEFORE SHE MADE ANY DECISIONS. THE INDICATION FOR USE WAS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530096 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR