BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 12070976 · Received June 25, 2021

    Report

    Report Number
    3004209178-2021-10008
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    June 25, 2021
    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
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT#: V955729, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 29-FEB-2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT'S LEAD WAS CHECKED EIGHT MONTHS AGO, AND FOUR OUT OF FIVE OF THE PATIENT'S 'LEADS' (EVIDENCE REASONABLY SUGGESTED 'ELECTRODES') WERE WORKING. THEY USUALLY COULD NOT GET PAST/USED TO NOT BE ABLE TO INCREASE PAST 2.5 VOLTS AND "HURTS SO BAD." IT HAPPENED WITH THEIR OLD DEVICE THAT ONLY THREE OF THE FIVE PROGRAMS WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966169 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR