BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2655135 · Received July 13, 2012

    Report

    Report Number
    3004209178-2012-05587
    Event Type
    Injury
    Date Received
    July 13, 2012
    Report Date
    June 18, 2012
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4) LOT# V840219 IMPLANTED: (B)(6) 2011 EXPLANTED: PRODUCT TYP LEAD PRODUCT ID (B)(4) LOT# V840219 IMPLANTED: (B)(6) 2011 EXPLANTED: PRODUCT TYP LEAD PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) PRODUCT TYP PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. THERE WAS A LEAD DISLODGEMENT OR MIGRATION, BUT NO SURGICAL REVISION. IT WAS NOTED WITH PROGRAM 4, STIMULATION WAS FELT BETWEEN THE RECTUM AND VAGINA. THERE WAS NO LEG DISCOMFORT, BUT THE LEG WAS TWITCHING. IT WAS REPORTED THERE WAS NO HOSPITALIZATION OR INJURY AS A RESULT OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT REPORTED THAT SHE DEVELOPED THE FLU AND A URINARY TRACT INFECTION BACK IN FEBRUARY AND SHE NOTICED A RETURN OF HER SYMPTOMS. THE PATIENT HAD NO STIMULATION ON THREE OF THE PROGRAMS IN THE INTERNAL NEUROSTIMULATOR (INS). WITH THE FOURTH PROGRAM THE PATIENT FELT STIMULATION IN HER BUTTOCK AREA. WHEN THE AMPLITUDE WAS INCREASED THE CRAMPING IN HER FEET INCREASED. THE PATIENT RECEIVED ASSISTANCE AND HER CONCERNS WERE RESOLVED.

    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