BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6214014 · Received December 29, 2016

    Report

    Report Number
    3004209178-2016-27439
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    April 30, 2016
    Report Date
    January 31, 2017
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT FELT SHOCKING EVERY 3 SECONDS AND THAT THEY HAVE NOT FOUND A POSITION THAT IS MORE COMFORTABLE. THE PATIENT STATED THEY ARE NOT ABLE TO GET TO THEIR PROGRAMMER. THE PATIENT¿S MANAGING PHYSICIAN IS OUT OF STATE AND THE PATIENT IS NOT ALLOWED TO LEAVE SO IT WAS RECOMMENDED THAT THE PHYSICIAN FROM THE PATIENT¿S CURRENT HOSPITAL CALL TO PAGE A MANUFACTURER REPRESENTATIVE TO TURN THE DEVICE OFF. THE PATIENT IS FEELING THE SHOCKING IN THEIR VAGINA AND GOING DOWN THE LEFT LEG.

    Description of Event or Problem · 1

    ON (B)(6) 2016. PATIENT THOUGHT THAT THEIR IMPLANT HAD BEEN COMPROMISED BECAUSE OF BEING GIVEN A SHOT OF ATIVAN (2MG) RIGHT WHERE THE DEVICE WAS (AGAINST THEIR WILL) . IMPLANT HAD NOT WORKED SINCE AND PATIENT WAS HAVING RETURN OF SYMPTOMS AND WHEN TRYING TO INCREASE STIMULATION, IT HURT. PATIENT WAS IMPLANTED FOR URINARY DYSFUNCTIONAL/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/ PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863310 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR