BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4296598 · Received December 4, 2014

    Report

    Report Number
    3004209178-2014-22543
    Event Type
    Injury
    Date Received
    December 4, 2014
    Report Date
    November 16, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V855059, 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 PATIENT HAD A LOSS OF THERAPEUTIC EFFECT IN (B)(6). SHE NOTICED AROUND (B)(6) THAT HER THERAPY WAS NOT WORKING FOR HER URGENCY. SHE ALSO HAD PARKINSON¿S AND HAD FALLEN SEVERAL TIMES. THE PATIENT WAS EXAMINED BY HER DOCTOR AND THE LEAD MAY HAVE BEEN DAMAGED. THE THERAPY HAD BEEN TURNED OFF FOR ¿ABOUT FOUR MONTHS¿ AND THE REPORTER CATHETERIZED THE PATIENT EVERY NIGHT. SHE WAS HAVING A REVISION THE DAY AFTER THE REPORT. NO PATIENT OUTCOME OR CONFIRMED LEAD DAMAGE WAS REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784071 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention