BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7001665 · Received November 3, 2017

    Report

    Report Number
    3004209178-2017-23160
    Event Type
    Injury
    Date Received
    November 3, 2017
    Report Date
    November 3, 2017
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE:: PRODUCT ID: 3889-28, LOT# V896802, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT IN A COUPLE YEARS COULD NOT REMEMBER THE YEAR IT WAS NOT WORKING LIKE IT USED TO. PATIENT MENTIONED THAT ¿TO HELL WITH IT, TOOK MEDICATION FOR THE BLADDER AND THEY HAD THE HEALTHCARE PROVIDER TO FIX IT OR TAKE IT OUT¿. THE PATIENT REMEMBERS MEETING WITH A REPRESENTATIVE "AND THEY TRIED TO HELP THE PATIENT WITH IT AND IT MIGHT HAVE HELPED FOR A DAY OR TWO BUT THAT¿S ABOUT IT. THAT EXPERIENCED LOSS OF THERAPY. THEY HAD THE LEAD AND IMPLANTED NEUROSTIMULATOR REPLACED. THE PATIENT INDICATORS FOR USE ARE FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779578 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention