BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4101448 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17350
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 27, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0E9KV, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2014 THE PATIENT HAD AN HCP APPOINTMENT WHERE THEY DID BOTOX ON THEM. AT THIS APPOINTMENT THE MANUFACTURER REPRESENTATIVE CAME IT TO CHECK THE DEVICE AND CONFIRMED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN OFF SINCE (B)(6) AND THE PATIENT DID NOT KNOW HOW IT GOT SHUT OFF. THE PATIENT DIDN'T TURN IT OFF AND MAYBE THE HCP'S ASSISTANT ACCIDENTALLY SWITCHED IT OFF BUT THEY DIDN'T KNOW. THE MANUFACTURER REPRESENTATIVE TURNED IT BACK ON AND TURNED THE INTENSITY UP. THE PATIENT'S SETTINGS USED TO BE 0.1V OR 0.2V AND NOW THEY WERE AT 2.4V. THE MANUFACTURER REPRESENTATIVE SET IT AT AN 8 AND THEY TRIED THAT FOR A MONTH BUT IT WAS INTENSE. THE PATIENT HAD BEEN GETTING BLADDER INFECTIONS EVERY MONTH SINCE (B)(6) AND DIDN'T KNOW IF THAT HAD TO DO WITH THE DEVICE BEING OFF. THE PATIENT DIDN'T KNOW IF THEIR MANUFACTURER REPRESENTATIVE WAS AWARE OF THE BLADDER INFECTIONS BUT THEY WERE UPSET THAT THE DEVICE WAS OFF ALL THE TIME SINCE (B)(6). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD VIBRATIONS IN THEIR LEFT LEG ON AND OFF FOR A COUPLE OF MONTHS BUT IN THE LAST COUPLE OF WEEKS THEY FELT A HOT SENSATION DOWN THEIR LEG AS WELL. SOMETIMES THE PATIENT WOULD LOOK DOWN TO SEE IF SOMETHING HOT POURED ON THEIR LEG. SINCE MAY THE PATIENT HAD HAD A BLADDER INFECTION EVERY MONTH AND THE INFECTION MADE THEM GO TO THE BATHROOM A LOT. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) WAS GOING TO TRY A BOTOX INJECTION TOMORROW AND THE PATIENT WANTED TO KNOW IF THAT WOULD WORK WITH THEIR THERAPY. THE PATIENT HADN¿T CHANGED THEIR SETTINGS SINCE (B)(6). THE PATIENT WAS GOING TO DISCUSS THEIR ISSUE WITH THEIR HCP TOMORROW. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581637 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention