BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2181583 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05181
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 9, 2007
    Report Date
    March 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED LEFT SIDE VAGINAL DISCOMFORT UNKNOWN TO SPECIFIC START DAY AND MONTH. THERE WERE NO INTERVENTIONS. IT WAS LATER REPORTED THAT (B)(6) 2009 THE PATIENT EXPERIENCED UNDESIRABLE CHANGE IN SENSATION OF STIMULATION WITH AN UNCOMFORTABLE, COOLING SENSATION LIKE IV FLUID FROM THE NAVEL TO THE PERINEUM. NO SURGICAL INTERVENTION WAS NOTED. IN LATER REPORTING FROM (B)(6)2011, IT WAS NOTED THAT THE PATIENT EXPERIENCED PAIN AT THE NEUROSTIMULATOR OR LEAD SITE WITH DISCOMFORT AT THE STIMULATOR SITE IN CERTAIN POSITIONS. THE DEVICE HAD BECOME VERY SUPERFICIAL. DATE OF ONSET WAS (B)(6) 2007. REPORTING FROM (B)(6) 2011 NOTED SENSATION OF ELECTRIC SHOCK OF STIMULATION WITH PAINFUL SHOCK SENSATION, LEFT/POSTERIOR SIDE OF VAGINA. PAIN WAS OCCURRING EVERY 8 SECONDS, WHICH WAS THE CYCLING MODE OF THE DEVICE. THE DATE OF ONSET WAS (B)(6) 2011. IN THE REPORTING FROM (B)(6) 2011, IT WAS NOT CLEAR IF SURGICAL INTERVENTION HAD OCCURRED. IN LATER REPORTING FROM (B)(6) 2011, PAIN AT NEUROSTIMULATOR OR LEAD SITE WAS NOTED. THE PATIENT WAS SEEN IN CLINIC ON (B)(6), 2010 WITH ISSUES OF HER DEVICE (BATTERY) HAD SHIFTED "FEELS MORE SENSITIVE TO PRESSURE" ON TELEPHONE VISIT ON (B)(6), 2010. THE PATIENT COULD FEEL MORE OF A "RIDGE" THAT WAS NOT THERE BEFORE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR IMPLANTED:| LEAD: MODEL 3889, LOT# J0527014V| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM019740P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH021390V| IMPLANTED:| EXPLANTED: