BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3040989 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04863
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 20, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 3889-28, LOT# VA05BFN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NOTICED A RETURN OF SYMPTOMS 3 DAYS PRIOR TO REPORT. THE PATIENT HAD NO FALLS OR TRAUMA AT THE TIME. THE PATIENT INCREASED THE DEVICE STIMULATION FROM 1.2 V TO 1.4 V AND WAS FEELING IT "STRONGLY BUT COMFORTABLY" AND WAS GOING TO LEAVE IT ON THE SETTING AND TRACK SYMPTOMS. APPROXIMATELY 2 WEEKS LATER IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT INCREASED DEVICE STIMULATION FROM 1.4 V TO 1.6 V AND WAS GOING TO TRACK SYMPTOMS. IT WAS STATED THAT A WEEK PRIOR THE PATIENT "FELT LIKE SHE HAD A URINARY TRACT INFECTION (UTI)" AND HAD NOTICED HER URGENCY STARTED TO COME BACK. THE PATIENT HAD CONTACTED HER HEALTH CARE PROVIDER BUT WAS FORWARDED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING DEVICE OR THERAPY BUT WAS WORKING WITH A MANUFACTURER'S REPRESENTATIVE OR HEALTHCARE PROVIDER. AN APPOINTMENT DATE OF (B)(6) WAS NOTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS NOT ¿HAVING LUCK¿ IN THE LAST 2 TO 3 WEEKS REGARDING THERAPY RELIEF FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD TRIED PROGRAM 1 AT 2.3 V (SETTING ON (B)(6) 2013) AND INCREASED TO 2.6 V BUT NOTED THAT THE STIM WAS ¿TOO MUCH¿, THEN TRIED SETTING 2.5 V (¿TOO MUCH¿), AND THEN 2.4 V (AGAIN TOO MUCH¿). THE PATIENT STATED THAT THE STIM WAS GOING TO THEIR RIGHT FOOT. THE PATIENT REPORTED A LOW BATTERY ICON ON THE PROGRAMMER UNIT. THE PATIENT CHANGED TO PROGRAM AT 1.2V. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE PATIENT HAD URGE INCONTINENCE AND HAD BEEN EXPERIENCING CONTACT URINARY TRACT INFECTIONS AND WAS ¿FINALLY¿ CLEAR FOR NOW AND WOULD LIKE TO ADJUST PROGRAMS. IT WAS STATED THAT THE PATIENT COULD FEEL STIMULATION AT 1.8 VOLTS, AND WOULD TRACK SYMPTOMS AT THIS SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142997 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention