BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5273228 · Received December 8, 2015

    Report

    Report Number
    3004209178-2015-23947
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V875083, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS SEEN SHORTLY AFTER AT THE HEALTH CARE PROVIDER'S (HCP'S) OFFICE. THE DEVICE WAS RESET AND THE PATIENT WAS FEELING STIMULATION AT THAT TIME.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE POWER ON RESET (POR) SCREEN WAS SEEN ON THE PATIENT PROGRAMMER. THE PATIENT HAD KNEE SURGERY ON EITHER ON (B)(6) 2015. THERE WERE NO FALLS OR TRAUMA THAT COULD BE RELATED TO THE ISSUE. THE MANUFACTURER REPRESENTATIVE WOULD HAVE THE PATIENT GO TO THE HEALTH CARE PROVIDER'S (HCP'S) OFFICE. NO SYMPTOMS WERE REPORTED. THE INDICATION FOR USE FOR THIS PATIENT WAS GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804348 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1