BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3913751 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12526
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 12, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-33, LOT# V015986, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND SHE WANTED THE SYSTEM REMOVED. THE PATIENT WAS LOOKING FOR A GOOD HEALTHCARE PROVIDER (HCP) TO PERFORM THE REMOVAL AND HAD MULTIPLE CONCERNS ABOUT REMOVAL. THE REMOVAL PROCEDURE HAD THE PATIENT ¿A LITTLE NERVOUS.¿ THE PATIENT WANTED THE SYSTEM OUT BECAUSE THE ¿BATTERY WAS NOT WORKING AND THE LEADS WERE BROKEN.¿ THE PATIENT STATED THAT THE THERAPY DID NOT HELP WITH HER URINARY INCONTINENCE, AT LEAST NOT MUCH, AND DID NOT HELP WITH HER FECAL INCONTINENCE. THE PATIENT CONTINUED TO STATE THAT WHEN SHE HAD IT DONE SHE SOMETIMES GOT GOOD RESULTS, BUT REALLY IT HAD NOT HELPED. THE PATIENT MENTIONED THAT SHE FOUND OUT THAT ¿TWO OF THE FOUR LEADS WERE NOT WORKING¿ TWO YEARS AGO. IT WAS CLARIFIED THAT THE PATIENT MEANT TWO OUT OF THE FOUR CONTACTS. THE PATIENT THEN WENT FOUR TO FIVE MONTHS AGO AND NOTHING WAS WORKING; IT WAS NOT INTERROGATING TO THE SYSTEM AND THE BATTERY WAS DEAD. THE PATIENT WENT ON TO STATE THAT SHE WAS ¿NOT SURE ABOUT THE LEAD.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390400 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1