BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3173738 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10468
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 13, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3 889-28 LOT# VA04M46, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED A CONSTANT SHOOTING PAIN IN THEIR TAILBONE/LOW BACK/UPPER BUTTOCK AREA THAT WENT FROM SIDE-TO-SIDE. THE PATIENT WAS NOT ABLE TO GET COMFORTABLE. THIS PAIN BEGAN ABOUT A WEEK AND A HALF PRIOR TO THE INITIAL REPORTING AND WAS NOTED AS NOT TO BE A JOLTING STIMULATION TYPE PAIN FROM THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT FELT THE STIMULATION DEPENDING ON THEIR POSITION. THE PATIENT¿S PHYSICIAN ADVISED THEM TO TRY TO ADJUST THE SETTINGS TO DETERMINE IF THE PAIN WAS DEVICE-RELATED. THE PATIENT WAS ABLE TO SYNCHRONIZE THE PROGRAMMER WITH THE INS BUT OBTAINED A ¿POOR COMMUNICATION¿ SCREEN MESSAGE ON THE UNIT. THE PATIENT WAS ADVISED TO TRY NEW BATTERIES IN THE PROGRAMMER. IT WAS LATER REPORTED THAT THE PATIENT HAD PAIN ON HER RIGHT SIDE. IT HAD BEEN COMING AND GOING THE LAST FEW DAYS BUT WORSENED LAST NIGHT SO THE PATIENT TURNED STIM OFF ABOUT 12:49AM AND SOME OF THE PAIN WENT AWAY. THE PATIENT DID NOT BELIEVE THIS PAIN WAS DEVICE RELATED. OVER THE LAST WEEK, THE PATIENT NOTED THAT WHEN SHE WAS SITTING, SHE TENSED UP NEAR HER TAILBONE. THE PATIENT ALSO NOTED CONSTANT PAIN IN HER LOWER BACK WHERE THE LEADS COME OUT OF THE INS AND ARE TUNNELED UNDER THE SKIN. THE PATIENT COULDN'T SIT, STAND OR WALK FOR AN EXTENDED PERIOD OF TIME BECAUSE OF THIS PAIN. THE PATIENT DESCRIBED THE PAIN AS THE PAIN YOU GET IN YOUR BACK WHEN YOU ARE BENDING OVER CHANGING A DIAPER - THIS STARTED ABOUT 3 WEEKS AGO. THE PATIENT'S DOCTOR ADVISED HER TO TRY TURNING STIM DOWN FOR A COUPLE DAYS THEN OFF FOR A COUPLE DAYS. WHEN STIM WAS OFF THIS PAIN GOES AWAY. STIM WAS ON. AN UNRELATED MEDICAL CONDITION WAS NOTED THAT THE PATIENT HAD LIVER DISEASE. IT WAS LATER REPORTED THE PATIENT HAD A REVISION DONE YESTERDAY (2013 (B)(6)) ON HER INS. THE INS WAS MORE DEEPLY IMPLANTED. INFORMATION REGARDING THE REVISION WAS ALSO REPORTED IN MANUFACTURER'S REPORT # 3004209178-2013-08643.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273827 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR