BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2882557 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12128
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 3, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# VA01PDF, IMPLANTED: 2012 (B)(6), 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 WENT TO SEE HER HEALTHCARE PROVIDER (HCP) ON (B)(6) 2012 AND A BULGE WAS FOUND OVER THE INCISION SITE. THE REPORTER STATED THAT THE HCP THOUGHT THAT "IT WAS THE LOOP OF THE WIRE THAT HAD COME UP CLOSE TO THE SURFACE OF THE SKIN". THE BULGE WAS REPORTED TO HAVE JUST "COME UP" A FEW DAYS BEFORE THAT DAY AND WAS GIVING THE PATIENT PAIN. THE REPORTER ALSO WANTED TO KNOW IF THIS HAD ANYTHING TO DO WITH ONE OF THE PATIENT'S PROGRAMS NOT WORKING. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS DOING FINE, BUT ON THE DAY AFTER HER APPOINTMENT WITH HER HCP, SHE HAD TO STRAIN TO PASS URINE AGAIN. THE REPORTER INDICATED THAT THE PATIENT WAS NOT HAVING ANY SYMPTOM RELIEF. IT WAS ALSO NOTED THAT THE PATIENT COULD NOT FEEL STIMULATION AT HER SETTING OF 5.0V AT THE TIME. THE PATIENT'S PROGRAM WAS CHANGED AND IT WAS INDICATED THAT THE PATIENT COULD FEEL STIMULATION ON THAT PROGRAM AT 1.0V. IT WAS STATED THAT SETTING WOULD BE TRIED TO SEE HOW SYMPTOMS GO. IT WAS ALSO NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED ON (B)(6) 2012 "TO HAVE ALL THE TESTS FOR HER TO HAVE SURGERY" DONE. THE SURGERY WAS SET UP FOR FOUR DAYS AFTER THE APPOINTMENT DATE TO ADDRESS THIS "LEAD BULGE" PROBLEM.

    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 Required Intervention