BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2939060 · Received February 1, 2013

    Report

    Report Number
    3004209178-2013-01219
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    May 1, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT# V073706, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID: 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION REGARDING THE EVENT, THE HEALTHCARE PROFESSIONAL REPORTED THAT THEY HAD NOT SEEN THE PATIENT SINCE (B)(6) 2012. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE LEAD THAT CONTROLLED VAGINAL STIMULATION WAS "NOT WORKING AT ALL." THE PATIENT SAW HER HEALTH CARE PROVIDER (HCP) IN (B)(6) 2012 AS THE "INS WAS NOT VERY FUNCTIONAL AT THAT TIME." THE HCP REPROGRAMMED THE DEVICE AND IT WAS DOING OK AS OF (B)(6) 2013. THE PATIENT REPORTED, THE LEAD WAS NOT WORKING IN (B)(6) 2012, AND WAS LATER ASSESSED AND IT WAS CONFIRMED THAT THE LEAD WAS BROKEN. THE PATIENT COULDN'T AFFORD TO HAVE THE LEAD REDONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44563 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR