BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3100423 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07394
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 22, 2013
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V979271, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS 2-3 DAYS PRIOR TO REPORT, AND STARTEDUSING PADS AGAIN. TROUBLESHOOTING WAS PERFORMED, AND PATIENT WAS ABLE TO ADJUST STIMULATION. THE PATIENT REPORTED FEELING STIMULATION IN HER FOOT. THE PATIENT WAS REFERRED TO HER HEALTH CARE PROVIDER FOR FURTHER ADJUSTMENT. FOLLOW-UP WITH THE PATIENT'S HEALTHCARE PROVIDER REPORTED THAT THE PATIENT LOST SOME OF THE EFFECT BECAUSE OF A URINARY TRACT INFECTION (UTI). THE UTI WAS REPORTEDLY TREATED. THERE WERE NO ABNORMAL IMPEDANCES MEASURED. PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200630 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention