BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4230609 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21032
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# J0417765V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE LAST 4.5 MONTHS THE PATIENT HAD BEEN DEALING WITH SOME BLADDER AND URINARY TRACT INFECTIONS (UTIS). THE PATIENT HAD VOIDING ISSUES OF FREQUENCY, PRESSURE, ¿INFECTION IN THE URINE ITSELF,¿ DISCOMFORT, AND PAINFUL, AND THEY BELIEVED THESE SYMPTOMS EXACERBATE THE INFECTION. THE PATIENT¿S SYMPTOMS WERE GRADUAL. THE PATIENT WAS TAKING 3000 MG OF ANTIBIOTICS EVERY DAY. THE PATIENT¿S DIAGNOSIS WAS INTERSTITIAL CYSTITIS (IC), AND THIS WAS THE REASON THE DEVICE WAS PLACED TO ADDRESS THE VOIDING ISSUES THAT CAME WITH IC. THE PATIENT WAS GOING TO SEE A HEALTH CARE PROVIDER (HCP) FOR THE FIRST TIME TOMORROW AND WANTED TO UPDATE THE MANUFACTURER ON WHAT WAS HAPPENING WITH THEM. THE PATIENT ASKED ABOUT SEEING A MANUFACTURER REPRESENTATIVE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714664 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention