BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8725410 · Received June 21, 2019

    Report

    Report Number
    3004209178-2019-12149
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    January 30, 2013
    Report Date
    June 21, 2019
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA03QZ1, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NEVER HAD THERAPEUTIC EFFECT. THE PATIENT THOUGHT THEIR SYMPTOMS HAD INCREASED BY FIFTY PERCENT SINCE IMPLANT. THEY SOAKED THROUGH FOUR OR FIVE PADS IN TEN HOURS. REPROGRAMMING HAD BEEN PERFORMED. THERAPY WAS UNCOMFORTABLE. THERAPY FELT LIKE A NERVE SHOOTING UP THEIR VAGINA. THE PATIENT FELT A PAINFUL, PULLING SENSATION WHEN THEY BEND AT THE WAIST. THE PATIENT DID NOT FEEL STIMULATION AT 3.0 V. INCREASING TO 3.1 V RESULTED IN STIMULATION SENSATION. ADDITIONAL INFORMATION WAS RECEIVED ON 2019-MAY-28 FROM THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE PATIENT REPORTED THAT THEY USED TO HAVE AN INTERSTIM II DEVICE BUT NOTED THAT IT HAD BEEN EXPLANTED BECAUSE IT NEVER REALLY WORKED FOR THEM AND IT WAS VERY UNCOMFORTABLE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518164 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention