BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2771856 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08872
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 17, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V588862, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND WAS NOT FEELING ANY STIMULATION SENSATION. THE PATIENT'S SYMPTOMS WERE PAIN AND THE RETURN OF INCREASED URINARY FREQUENCY. PATIENT DID NOT THINK HER DEVICE WAS WORKING ANYMORE DUE TO HER SYMPTOMS ESPECIALLY IN THE PAST WEEK. PATIENT HAD NOT FOLLOWED-UP WITH HER DOCTOR SINCE IMPLANT, AND DOES NOT CURRENTLY HAVE A DOCTOR MANAGING HER DEVICE DUE TO RELOCATING. THE PATIENT HAD BEEN PEEING AT LEAST 5 TIMES A NIGHT FOR THE PAST 2-3 DAYS. PATIENT HAD BEEN GIVEN FOUR PROGRAMS ABOUT A YEAR AGO AND TRIED ALL OF THEM, BUT CANNOT FEEL STIMULATION EVEN WHEN SHE TURNS THEM ALL THE WAY UP. THE PATIENT FELL IN EARLY AUGUST AND HAD A PUNCTURE WOUND FROM A CANDLE STICK 1" BELOW HER STIMULATOR. SHE ALSO HAD PAIN NEAR HER INCISION SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1