BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3690456 · Received March 20, 2014

    Report

    Report Number
    3004209178-2014-04730
    Event Type
    Injury
    Date Received
    March 20, 2014
    Report Date
    February 25, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3023, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3886, LOT# L97844, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V052586, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE MANUFACTURER'S REPRESENTATIVE CONTACTED THE PATIENT AND GAVE HER THE PHONE NUMBER OF THE AREA INTERSTIM REPRESENTATIVE IN ORDER FOR HER TO GET HER DEVICE CHANGED OUT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NO STIMULATION SENSATION FOR AT LEAST SIX MONTHS. WHEN THE PATIENT TRIED TO CONNECT TO THE IMPLANTABLE NEUROSTIMULATOR (INS), THEY SAW A ? ON THE PATIENT PROGRAMMER SCREEN. THE PATIENT WANTED TO MEET WITH A MANUFACTURING REPRESENTATIVE TO CHECK THE INS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. NO STIMULATION SENSATION WAS NOTED. IN (B)(6) 2013, THE PATIENT NOTICED HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS ACTING UP AND THEN IN (B)(6) 2013, IT DIED. THE PATIENT WAS NOT ABLE TO CONNECT WITH THE INS EITHER. THE INS BATTERY DEPLETION WAS NORMAL. THE PATIENT DIDN'T HAVE A HCP (HEALTHCARE PROVIDER) BECAUSE, HE LEFT THE PRACTICE. THE PATIENT WAS LOOKING FOR A NEW HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERAPY STOPPED ON (B)(6) 2013. THE PATIENT WAS IN CLINIC TODAY AND THE MANUFACTURER'S REPRESENTATIVE COULD NOT READ HER IMPLANT BECAUSE OF WRONG APP CARD. THE REPRESENTATIVE FOUND OUT THAT THE IMPLANT IS AN INTERSTIM AND IT WAS USED FOR BLADDER PAIN AND ADDRESSED SOME LUMBAR PAIN AS WELL. THE REPORTER WONDERED IF THE LEADS WERE COMPATIBLE WITH SCS. REASON FOR CALL WAS NOTED AS PROGRAMMING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166383 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention