BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2992500 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03433
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 14, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# VA01W5T, IMPLANTED: (B)(6) 2012, 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 PAIN AT THE SITE OF HER IMPLANTABLE NEUROSTIMULATOR (INS) AND "DOWN HER LEFT LEG". IT WAS FURTHER REPORTED THAT THE PAIN OCCURRED FOLLOWING DIATHERMY "ON THE PATIENT'S LEFT KNEE". IT WAS UNKNOWN AT THE TIME OF REPORT WHETHER THE DIATHERMY PROCEDURE WAS "ULTRASONIC OR RADIO FREQUENCY" BASED. IT WAS NOTED THAT THE PATIENT'S INS WAS LOCATED "IN HER LEFT BUTTOCK". THE PATIENT WAS REPORTED TO HAVE STOPPED USING HER INS "THE EVENING AFTER DIATHERMY THERAPY". IT WAS ADDITIONALLY NOTED THAT THE PATIENT'S "PAIN DID GO DOWN ABOUT 50% WHEN THE DEVICE WAS OFF". IT WAS REPORTED THAT THERE WERE "NO RECENT FALLS OR TRAUMAS". THE PHYSICIAN ALSO REPORTED "MODESTLY EFFECTIVE THERAPY SINCE IMPLANT". DURING A PROGRAMMING SESSION THE PATIENT REPORTED THAT SHE "DID NOT FEEL STIMULATION IN THE THERAPY LOCATION, ONLY AT THE POCKET SITE". THE IMPEDANCE VALUES BETWEEN ELECTRODES 0 AND 2 WAS 1762 OHMS AND BETWEEN 0 AND 3 WAS 2697 OHMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97336 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1