BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2846716 · Received November 27, 2012

    Report

    Report Number
    3004209178-2012-10797
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    October 31, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V941222, 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 "INTERMITTENT" STIMULATION. IT WAS STATED THAT THE PATIENT DID NOT FEEL THE STIMULATION AND HER SYMPTOMS RETURNED "A LITTLE BIT." IT WAS NOTED THAT THIS STARTED "A WEEK AGO." THE PATIENT REPORTEDLY INCREASED HER STIMULATION TO 6.2 VOLTS ON PROGRAM 1, AND DID NOT FEEL THE STIMULATION. IT WAS STATED THAT THE PATIENT FELT THE STIMULATION "INTERMITTENTLY" ON PROGRAM 2 AT 1.6 VOLTS. IT WAS INDICATED THAT THERE WERE NO FALLS, TRAUMA, OR MEDICAL PROCEDURES. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN IN 2 WEEKS. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR DOCTOR OR THE MANUFACTURER REPRESENTATIVE. IT WAS STATED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2012 AND HAD FUTURE APPOINTMENTS PLANNED. NO FURTHER INFORMATION WAS REPORTED.

    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