BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM EXTERNAL

    MDR report key: 3983470 · Received August 6, 2014

    Report

    Report Number
    3007566237-2014-02196
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATES SINCE SHE HAD THE TEMPORARY LEAD PUT IN THREE DAYS BEFORE REPORTED EVENT DATE, SHE HAS NOT BEEN ABLE TO HAVE A BOWEL MOVEMENT. THE PATIENT STATES SHE GOT THE DEVICE TO HELP WITH FECAL INCONTINENCE. THE PATIENT STATES SHE FEELS LIKE SHE WAS COMPLETELY BLOWN UP. THE PATIENT STATES THE BOWEL MOVEMENT WAS RIGHT OUTSIDE AND AT THE "HOLE" AND SHE CAN'T STRAIN HARD ENOUGH TO "GET IT OUT." THE PATIENT STATES SHE WAS ABLE TO "RAKE SOME OUT" AT LUNCH BUT SHE STATES IT'S LIKE SHE HAS BLOWN UP ALL THE WAY TO HER CHEST. THE PATIENT STATES SHE SPOKE TO MANUFACTURER TWO DAYS BEFORE REPORTED EVENT DATE AND INFORMED THEM OF THE SITUATION. THE PATIENT STATES SHE TOLD HER THAT IT COULD TAKE 2-3 DAYS BEFORE SHE HAD A BOWEL MOVEMENT. THE PATIENT STATES WHEN SHE SPOKE TO THIS WOMAN, SHE TOLD HER TO CUT IT DOWN TO TWO AND THAT SHE DIDN¿T' HAVE TO FEEL IT FOR IT TO WORK. THE PATIENT STATES SHE SPOKE TO THE NURSE AT THE HCP'S (HEALTHCARE PROVIDER¿) OFFICE AND SHE RECOMMENDED SHE TAKE (B)(6). THE PATIENT STATES SHE ALSO RECOMMENDED THE PATIENT GET INTO HOT WATER. THE PATIENT STATES SHE DOESN'T THINK SHE HAS MORE THAN ONE SIDE IMPLANTED. THE PATIENT STATES SHE WAS HAVING PAIN AND SORENESS ACROSS HER BACK FROM WHATEVER THEY DID THREE DAYS BEFORE REPORTED EVENT DATE. THE PATIENT STATES IT ALSO BURNS. THE PATIENT STATES IF SHE TRIES TURNING STIMULATION DOWN ANYMORE, SHE NO LONGER FEELS STIMULATION. THE PATIENT SYMPTOMS OCCURRED SINCE IMPLANT OF TRIAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING COMPLAINTS OF SEVERE PAIN SHE SPOKE TO HER HEALTHCARE PROVIDER THE DAY BEFORE REPORTED EVENT DATE AND WAS THINKING OF GOING TO THE ER (EMERGENCY ROOM) TODAY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459647 INTERSTIM EXTERNAL STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention