BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5274207 · Received December 8, 2015

    Report

    Report Number
    3004209178-2015-23974
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Report Date
    November 11, 2015
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V890309, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER INITIALLY REPORTED ON (B)(6)THE DEVICE MOVED WITHIN OR FROM THE POCKET. NO ONE PARTICULAR EVENT WAS BELIEVED TO HAVE PROMPTED THIS. SYMPTOMS INCLUDED PAIN IN THE PATIENT'S BUTTOCKS AND PRIVATES FROM THE STIMULATION; THE PAIN WAS DESCRIBED AS A TEN, BURNING, CONSTANT AND PULSATING. TURNING STIMULATION DOWN DID NOT HELP. THE PATIENT WENT TO HER REGULAR DOCTOR AND THEY ADVISED HER TO CALL MANUFACTURE REPRESENTATIVE. A POSSIBLE DEVICE REMOVAL WAS CONSIDERED BY THE PATIENT. THE INDICATIONS FOR USE INCLUDED URINARY DYSFUNCTION AND GASTROINTESTINAL/PELVIC FLOOR. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED HAVING TROUBLE WITH THE DEVICE "SINCE LAST YEAR" AS IT INTERFERED WITH THE NERVES IN THEIR BACK AND LEGS. CAUSE, ACTIONS, AND OUTCOME REMAIN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803855 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR