BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3221356 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11629
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 18, 2013
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3 093-33, LOT# V973753, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAST NIGHT THE PATIENT WAS SITTING AT HER COMPUTER AND NOTED A SHOCK AROUND THE TAILBONE AREA, ON THE RIGHT SIDE OF THE BUTT CHEEK AND EXTREMELY PAINFUL. IT WAS NOTED THAT THE PATIENT COULD HARDLY WALK. THE PATIENT TURNED STIM DOWN TO 0.0V AROUND 2:30AM THIS MORNING AS IT WAS UNBEARABLE. THE PAIN WAS RIGHT AT THE TAILBONE AND THE PATIENT WAS WONDERING IF LEAD MIGRATES. THE INS WAS IMPLANTED ON THE LEFT SIDE. WHEN THE PATIENT PUTS HER FINGER ON HER TAILBONE IT HURTS. THE PATIENT SAW CHANGE IN SYMPTOMS ABOUT 2 MONTHS AGO BUT SHE DID NOT USE THE PATIENT PROGRAMMER FOR ABOUT 6 MONTHS. THE PATIENT NOTED SHE SHOULD HAVE DONE SOMETHING WITH THE PATIENT PROGRAMMER WHEN SHE NOTED CHANGES IN SYMPTOMS BECAUSE IT WAS GETTING WORSE. THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD CONCERNS REGARDING IF IT WAS POSSIBLE FOR LITTLE ELECTRODES/LEADS TO COME LOOSE. THE PATIENT DID NOT HAVE A FALL OR TRAUMA. THE PATIENT HAD BEEN WORKING IN HER GARDEN A LOT LATELY. THE PATIENT SYNCED WITH PATIENT PROGRAMMER. INS WAS OFF ON P4 AT 0.0V. THE PATIENT CALLED HER HCP (HEALTHCARE PROVIDER'S) OFFICE AND THEY TOLD HER TO CALL THE MANUFACTURER'S REPRESENTATIVE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320620 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR