BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3840411 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01481
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE TRIAL PATIENT HAD STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THE TRIAL REDUCED THE FREQUENCY OF THE PATIENT¿S URINATION AND REDUCED THEIR SYMPTOMS BY FIFTY PERCENT FOR ONE DAY. IT WAS REPORTED THE STIMULATION MOVED FROM THE BLADDER TO THE BUTTOCKS THE NEXT DAY AND THE PATIENT LOST SYMPTOM RELIEF. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE SUGGESTED AN X-RAY TO SEE IF THE LEADS HAD MOVED. IT WAS REPORTED THE PATIENT¿S TRIAL ENDED THE DAY PRIOR TO CALL. IT WAS NOTED THE PATIENT FELT A DIFFERENCE WITH BENDING AND TWISTING. IT WAS REPORTED THE PATIENT FELT AS THOUGH THE LEAD HAD MOVED. IT WAS NOTED THE PATIENT WANTED THE IMPLANT, BUT WANTED A FULL TRIAL FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317985 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1