BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2966225 · Received February 18, 2013

    Report

    Report Number
    3004209178-2013-02760
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3093-28 LOT# V022882, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4) IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND AN END OF SERVICE MESSAGE ON THEIR DEVICE. THE PATIENT STATED THEY FELT SHOCKING IN THE MIDDLE OF THE VAGINAL AREA ONE TIME, APPROXIMATELY ONE WEEK PRIOR TO REPORT. THE PATIENT ALSO STATED THEY HAD BEEN FALLING A LOT AND MAY HAVE FALLEN ON THE DEVICE. THE PATIENT ALSO REPORTED THEY WERE NOT ABLE TO ADJUST THE STIMULATION AND REPORTED SEEING AN "INS (IMPLANTABLE NEUROSTIMULATOR) OFF ICON" AND "ICON INDICATING INS BATTERY LOW" DISPLAYED ON THEIR PROGRAMMER. WHILE TRYING TO DECREASE THE SETTING, THE PATIENT RECEIVED AN END OF SERVICE MESSAGE ON THEIR PATIENT PROGRAMMER. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70262 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR