BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3935846 · Received July 15, 2014

    Report

    Report Number
    3007566237-2014-01961
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4). F

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERSTIM FOR URINARY BLADDER CONTROL TRIAL PATIENT STATED THE TRIAL BEGAN YESTERDAY AND THE PATIENT COULD FEEL THE STIM IN HER ANAL AREA BUT AROUND 6PM (1.5HRS POST TRIAL IMPLANT) LAST NIGHT IT BEGAN THROBBING AND HURTING IN THAT AREA. THE PATIENT NEVER TOLD THE DOCTOR OR MANUFACTURER'S REPRESENTATIVE ABOUT THIS BECAUSE SHE WAS NOT SURE WHERE OR HOW SHE WAS FEELING THE STIM AT THE TIME OF THE TRIAL IMPLANT. THIS OCCURRED IF SHE IS SITTING DOWN OR WALKING AROUND. THE PATIENT ALSO STATED SHE HAS HAD NO SYMPTOM RELIEF SINCE THE TRIAL BEGAN. THE PATIENT TRIED TURNING THE SETTINGS DOWN BUT THEN FELT NO STIM. THE PATIENT REQUESTED TO SPEAK WITH HER MANUFACTURER'S REPRESENTATIVE. ADDITIONAL INFORMATION RECEIVED NOTED THAT THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION. THE EVENT CAUSE WAS NOT DETERMINED. IT WAS UNKNOWN IF IT WAS DEVICE RELATED. IT WAS UNKNOWN IF REPROGRAMMING WAS NEEDED. THE PATIENT COMPLAINED OF PAIN FOLLOWING LEAD PLACEMENT. THE PERCUTANEOUS LEAD WAS REMOVED. THE PATIENT WAS RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414040 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention