BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2900461 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00275
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 435135, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID: 435135, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT A PATIENT HAD TWO DEVICE SYSTEMS FOR SEPARATE THERAPIES. IT WAS UNCLEAR IF ALL OR ANY OF THE REPORTED INFORMATION RELATED TO THIS DEVICE AND THERAPY OR IF IT RELATED ONLY TO THE PATIENT'S OTHER DEVICE AND THERAPY. IT WAS REPORTED THAT A PATIENT HAD PARALYSIS THROUGHOUT HER INTESTINES, WHICH WAS HOW "EVERYTHING GOT GOING". IT WAS UNCLEAR IF THIS OCCURRED BEFORE DEVICE IMPLANT. THE REPORTER STATED THAT THE PATIENT HAD SHARP, STABBING PAINS ON THE LOWER BACK ALONG THE "PANT LINE" AND ALONG THE LEFT LEG, AND THE RIGHT HAND WOULD START TO SHAKE. IT WAS NOTED THAT IT ALWAYS ACHED AROUND THAT AREA. THE PAIN STARTED "IMMEDIATELY AFTER IMPLANT". IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED VERY CLOSE TO THE SKIN AND THE PATIENT WAS ABLE TO SEE THE DEVICE. IT WAS NOTED THAT THE PATIENT WAS VERY THIN, AND SHE STATED THAT IF SHE TRIED TO MOVE THE DEVICE SHE COULD. THE REPORTER STATED THAT THE DEVICE MIGHT BE LOOSE IN THE POCKET AND POKED OUT OF THE PATIENT'S SKIN. THE PATIENT HAD SOME FALLS WITHIN THREE WEEKS AFTER HER SURGERY. IT WAS REPORTED THAT THE PATIENT TRIPPED OVER HER DOG AND HAD "UNBEARABLE PAIN" AND IT WAS "LIKE A COMPLETE SHOCK" AND SHE SCREAMED. THE PATIENT ALSO HAD A FALL AT HER HOME WHERE SHE "FOUND HERSELF ON HARDWOOD FLOOR WITH A CUT ON HER EYE". IT WAS UNCLEAR IF THE FALLS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE PATIENT "HAD THEM ALL THE TIME MILDLY". IT WAS UNCLEAR IF THIS REFERRED TO FALLS OR SOMETHING ELSE. IT WAS NOTED THAT THE PATIENT HAD THREE SEIZURES BECAUSE OF HER LOW BLOOD PRESSURE. THE REPORTER STATED THAT WHEN THE PATIENT BENT OVER SHE HAD A LOT MORE PAIN THAN WHEN SHE WAS UPRIGHT. IT WAS REPORTED THAT THE PATIENT WAS ON A "KING OF HEARTS MONITOR" FOR THE LAST 30 DAYS, AND THE DEVICE WAS TURNED OFF FOR THE ENTIRE TIME. IT WAS NOTED THAT THE PATIENT WAS NOT CONFIDENT THAT HER DOCTOR WAS KNOWLEDGEABLE ABOUT THE DEVICE. THE REPORTER STATED THAT THE DOCTOR "WOULDN'T TOUCH" THE DEVICE UNLESS THE PATIENT ASKED HIM TO. IT WAS REPORTED THAT THE DOCTOR STATED THAT THE MOVEMENT OF THE DEVICE WAS NORMAL. IT WAS NOTED THAT THE DEVICE HELPED THE PATIENT'S BOWEL SYMPTOMS AND THE DEVICE WAS WORKING SO SHE DIDN'T WANT TO TAKE IT OUT. THE REPORTER STATED THAT THE MANUFACTURER REPRESENTATIVES WERE CONCERNED ABOUT THE PLACEMENT OF THE DEVICE BUT THE DOCTOR DIDN'T WANT TO MOVE IT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PREVIOUSLY REPORTED EVENT PERTAINED TO THE PATIENT'S INTERSTIM DEVICE. THE FOLLOW UP INFORMATION TO THE EVENT PREVIOUSLY REPORTED UNDER THIS MANUFACTURER REPORT NUMBER CAN BE FOUND IN MANUFACTURER REPORT #3004209178-2013-00348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7133 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1