BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2940408 · Received February 3, 2013

    Report

    Report Number
    3004209178-2013-01240
    Event Type
    Injury
    Date Received
    February 3, 2013
    Report Date
    January 10, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V735260, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF BLADDER CONTROL A YEAR PREVIOUS TO THIS REPORT. IT WAS STATED THAT PROGRAMMING WAS "NOT AS EFFECTIVE" FOR THE PATIENT'S SYMPTOMS. AN X-RAY SHOWED THAT "THINGS SEEMED TO BE IN PLACE." THE PATIENT STILL FELT THE "FLUTTERING SENSATION" AS OF 6 MONTHS PREVIOUS TO THIS REPORT. IT WAS ADDITIONALLY NOTED THE STIMULATION WAS SHUT OFF FOR ONE MONTH AND THE TURNED BACK ON. IN (B)(6) 2012, IT WAS STATED THE PATIENT WAS HAVING CONCERNS WITH THEIR DEVICE OR THERAPY AND WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS STATED "IT FAILED AFTER WORKING FOR 5 MONTHS." IT WAS STATED "IT WAS SHUT OFF AFTER 1 YEAR." AS OF THE DATE OF THIS REPORT, IT WAS INDICATED THE DEVICE WORKED WELL FOR ABOUT 5 MONTHS AND THEN JUST "STOPPED WORKING." IT WAS UNCLEAR WHY IT STOPPED WORKING. IT WAS INDICATED A NEW DEVICE WAS IMPLANTED IN THE PATIENT IN (B)(6) 2013. IT WAS NOTED THAT THE NEW DEVICE WAS NOT WORKING WELL "JUST LIKE WHEN THE PREVIOUS DEVICE FAILED." FIVE DAYS LATER, IT WAS STATED THE DEVICE THAT WAS REPLACED DEPLETED NORMALLY. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45716 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention