BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2628173 · Received June 26, 2012

    Report

    Report Number
    3004209178-2012-04835
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Report Date
    May 29, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    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 3093-33, LOT# V833270, 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 FELT NO STIMULATION. THE PATIENT STATED THE STIMULATION WAS OFF AND HE BELIEVED IT SHOULD HAVE BEEN ON. THERE WAS A LACK OF RELIEF FROM URGENCY/FREQUENCY SYMPTOMS. THE SETTINGS WERE CHANGED FROM GROUP 2 TO GROUP 3 AT 1.8 VOLTS. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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