BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2903435 · Received January 9, 2013

    Report

    Report Number
    3007566237-2013-00077
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR STIMULATOR REPLACED BECAUSE IT "WASN'T WORKING." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2012. THAT WAS THE LAST TIME THEY HAD HEARD FROM THE PATIENT. IT WAS NOTED THAT THE ONLY DEVICE THE PATIENT EVER HAD WAS THE ONE PLACED ON (B)(6), 2011. NO OTHER SURGERIES OR REPLACEMENTS WERE ON FILE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12220 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention