BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5148049 · Received October 14, 2015

    Report

    Report Number
    3004209178-2015-20540
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Report Date
    September 16, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V833270, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT SHE WAS DOING A LOT OF HEAVY LIFTING AND GETTING UP AND DOWN STAIR WHEN MOVING FROM (B)(6). IT WAS INDICATED THAT SHE WAS REPROGRAMMED BY A COMPANY REPRESENTATIVE AND WAS DOING WELL. THE REPORT OF LACK OF PROGRAMS ON PATIENT PROGRAMMER HAD BEEN RESOLVED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED HAVING A GRADUAL RETURN OF SYMPTOMS IN (B)(6) 2015 AND WAS NOT SURE IF THE DEVICE WAS WORKING. THE PATIENT MET WITH THEIR DOCTOR ON (B)(6) 2015 WHERE REPROGRAMMING WAS ATTEMPTED WHICH RESULTED IN "SOME" CONTROL OF HER SYMPTOMS. HOWEVER, LATER THAT NIGHT, THE STIMULATION CAUSED VERY PAINFUL STIMULATION IN THE VAGINAL AREA. EVENTUALLY THE PAINFUL STIMULATION WENT AWAY, BUT THE PATIENT AGAIN HAD A RETURN OF SYMPTOMS IN (B)(6) 2015 FOLLOWING THE APPOINTMENT. DURING THE CALL, THERE WERE NOT ANY PROGRAMS ON THE PROGRAMMER SCREEN. STIMULATION WAS CONFIRMED TO BE ON, BUT THE PATIENT WAS NOT FEELING STIMULATION AND HAD NO CONTROL OF HER SYMPTOMS; THE PATIENT HAD TO GO THROUGH A LOT OF PADS. CAUSE, ACTIONS, AND OUTCOME REMAIN UNKNOWN. FOLLOW UP WAS CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. THE INDICATIONS FOR USE INCLUDED URINARY DYSFUNCTION AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680751 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR