BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3050668 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05871
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    September 24, 2011
    Report Date
    May 13, 2021
    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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3093-33, LOT#: V779595, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID: 3037, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION AND NEVER HAVING THERAPEUTIC EFFECT. THE PATIENT WAS NOT REACHING A 50% REDUCTION IN SYMPTOMS AND SOMETIMES FELT PAIN. IT WAS NOTED THAT THE INS WAS BENEFICIAL AT FIRST BUT THE PATIENT FELL (B)(6) 2011. THE PATIENT WENT A YEAR TRYING TO REPROGRAM INS AND THE PHYSICIAN STATED THAT THE CONNECTION WAS "AN INCH AND A HALF OFF." THE PATIENT HAD A REVISION (B)(6) 2012. SINCE THEN, THE PATIENT HAD NO THERAPEUTIC RELIEF AND HAD PAIN. THE PATIENT WAS WONDERING IF THEY SHOULD CONTINUE TO INCREASE INS. THE PATIENT SWITCHED PROGRAMS (B)(6) 2013 AND STATED IT WAS BETTER THAN THE PREVIOUS PROGRAM BUT WAS STILL NOT GIVING HER RELIEF. THE PATIENT WAS ON PROGRAM 2 AT 1.2V AND WAS GOING TO CONTINUE ON CURRENT PROGRAM. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148038 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention