BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3079969 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06949
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 9, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V251861, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT URINARY TRACT INFECTIONS (UTIS) "REGULARLY" AND WAS CATHETERIZED 4 TIMES A DAY. IT WAS NOTED THAT THE PATIENT HAD "AN ADDITIONAL UTI" IN (B)(6) 2012. IT WAS UNCLEAR HOW MANY UTIS THE PATIENT HAD. THE PATIENT REPORTEDLY HAD AN URODYNAMIC TEST DONE AND SPENT 4 DAYS IN THE HOSPITAL BEGINNING ON (B)(6) 2013. THE REPORTER ALSO INDICATED THAT THE PATIENT FELL ABOUT A MONTH PRIOR TO THE REPORT AND HAD NOT BEEN ABLE TO USE HIS PROGRAMMER SINCE THEN. A POOR COMMUNICATION SCREEN WAS BEING DISPLAYED ON THE PROGRAMMER. IT WAS NOTED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) HADN'T BEEN NOTIFIED OF THE FALL. THE PATIENT ONLY WORKED WITH A NURSE WHO PERFORMED THE URODYNAMIC TEST. THE REPORTER STATED THAT THE PATIENT HAD MULTIPLE SCLEROSIS (MS) AND NEEDED TO HAVE AN MRI DONE ON THE CERVICAL SPINE AND LESIONS IN THE BRAIN. AS SUCH, THE IMPLANTABLE NEUROSTIMULATOR (INS) NEEDED TO BE TAKEN OUT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181041 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention