BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4200182 · Received October 24, 2014

    Report

    Report Number
    3007566237-2014-03111
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE DID NOT REMEMBER THE LEAD BEING ATTACHED TO THE WRONG NERVE. THE PATIENT WENT FROM LEAKING EIGHT TIMES A DAY TO TWICE AND FROM FIVE PADS TO TWO. THE PATIENT FELT STIMULATION IN THE CORRECT AREA AT 0.8 V. DIFFERENT PROGRAMMING WAS ATTEMPTED BEFORE SWITCHING THE LEAD AND TRYING A SECOND TRIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED THE TRIAL ON (B)(6) 2014 AND SINCE THE TRIAL STARTED THEY WEREN¿T HAVING GOOD RESULTS. THE PATIENT STARTED TO HAVE PROBLEMS THE DAY AFTER THE TRIAL STARTED AND THE DEVICE WAS STILL NOT WORKING RIGHT. THE PATIENT WAS GETTING JUST A LITTLE REDUCTION IN SYMPTOMS AND WAS VOIDING LESS BUT STILL HAD ACCIDENTS. THE PATIENT HAD 9 VOIDS IN 24 HOURS AND 4 OF THE VOIDS WERE URGENT AND THE PATIENT HAD TO CHANGE THEIR PADS. THE PATIENT HAD 1 LEAK IN THE LAST 24 HOURS AND WAS FEELING SHOCKING IN THE VAGINAL AREA NEAR THE ANUS. THE PATIENT DID NOT FEEL ANY STIMULATION AFTER THE INITIAL SHOCK SENSATION. THE PATIENT HAD SPOKEN WITH THEIR HEALTH CARE PROVIDER (HCP) AND THE NURSE SPOKE WITH THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2014. THE PATIENT SPOKE WITH SOMEONE THIS MORNING AND THEY HELPED THE PATIENT MAKE ADJUSTMENTS BUT THE ADJUSTMENTS DID NOT HELP RESOLVE THE ISSUE. IT WAS LATER REPORTED THAT THE TRIAL DID NOT WORK BECAUSE IT WAS ATTACHED TO THE WRONG NERVE AND THE PATIENT HAD STARTED A NEW TRIAL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679934 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1