BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3950975 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13372
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    March 4, 2014
    Report Date
    June 27, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # VA00GJX, IMPLANTED: (B)(6) 2012, 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 CLINICAL DIAGNOSIS WAS INCREASED IN URGE INCONTINENCE AND URINARY TRACT INFECTION. IT WAS NOTED THAT THE PATIENT HAD A URINARY TRACT INFECTION ON (B)(6) 2014. IT WAS NOTED THAT A URINE CULTURE WAS DONE ON THE SAME DAY AND WAS POSITIVE. IT WAS NOTED THAT THE PATIENT WAS PRESCRIBED CIPRO 250 MG. IT WAS NOTED THAT THE PATIENT TOOK ANTIBIOTICS FOR 4 DAYS. IT WAS NOTED THAT THE URINE CULTURE WAS REPEATED ON (B)(6) 2014 AND THE CULTURE RESULTS WERE NEGATIVE. IT WAS NOTED THAT THE PATIENT VISITED THE OFFICE ON (B)(6) 2014 BECAUSE SHE WAS IN A BOAT ACCIDENT OVER THE PAST WEEKEND AND NOW HAD INCREASED IN URGE INCONTINENCE. IT WAS NOTED THAT THE DOCTOR CHECKED IMPEDANCES AND ALL WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) POSITION WAS FINE AND THERE WAS NO TENDERNESS OVER THE GENERATOR OR LEAD. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF INFECTION. IT WAS NOTED THAT LUMBAR SPINE 2 OR 3 VIEWS WERE DONE WHICH SHOWED NORMAL EXAMINATION OF LUMBAR SPINE. IT WAS NOTED THAT THE STIMULATOR WITH A LEAD IN THE RIGHT AS 4 NEURAL FORAMEN. IT WAS NOTED THAT ACTIONS TAKEN INCLUDED UNSCHEDULED CLINIC OR OFFICE VISITS. IT WAS NOTED THAT DIAGNOSTIC METHODS INCLUDED IMAGING AND LABORATORY TESTING. IT WAS NOTED THAT THE EVENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT LABORATORY TESTING ON (B)(6) 2014 WHICH SHOWED ABNORMAL URINE CULTURE WAS POSITIVE AND LABORATORY TESTING ON (B)(6) 2014 SHOWED NORMAL FOR THIS SUBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427872 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention