BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2904204 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00348
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# VA002AP, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED AT THE END OF (B)(6) 2013. THE REPORTER STATED THAT IT WAS FOUND THAT THE LEAD HAD BEEN LOOSE AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS AT THE BELT LINE AND RUBBING AGAINST THE PATIENT'S SKIN. IT WAS REPORTED THAT THE PATIENT REQUESTED THAT THE DEVICE BE RELOCATED FURTHER INTO THE BUTTOCK SINCE THE THERAPY WAS WORKING WELL FOR HER, BUT HER DOCTOR WAS NOT WILLING TO DO SO AND DECIDED TO EXPLANT THE DEVICE. THE REPORTER STATED THAT PRIOR TO DEVICE REMOVAL THE DEVICE WAS TENDER, THE PATIENT HAD SWELLING INTO THE HIP AND LEG, AND IT WAS UNCOMFORTABLE FOR THE PATIENT TO LIE ON HER BACK AND TO WEAR PANTS. IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM FOR LOW BLOOD PRESSURE AND A SYNCOPAL EPISODE THAT THE PATIENT DID NOT THINK WAS RELATED TO THE DEVICE, AND HER DOCTOR WAS CONTACTED ABOUT AN EKG AND CT. IT WAS REPORTED THAT THE DOCTOR STATED THAT THE DEVICE DIDN'T NEED TO BE TURNED OFF FOR THE SCANS. IT WAS NOTED THAT THE BLOOD PRESSURE HAD RESOLVED AND THE CAUSE WAS NOT KNOWN. THE REPORTER STATED THAT THE PATIENT RECOVERED WELL AFTER SURGERY AND THE PAIN HAD RESOLVED.

    Description of Event or Problem · 1

    IT WAS NOTED THAT A PATIENT HAD TWO DEVICE SYSTEMS FOR SEPARATE THERAPIES. IT WAS UNCLEAR IF SOME OR ALL OF THE REPORTED INFORMATION RELATED TO THIS DEVICE AND THERAPY OR IF SOME OF THE INFORMATION RELATED TO THE PATIENT'S OTHER DEVICE AND THERAPY. SEE MFR REPORT # 3004209178-2013-00275. 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 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11635 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention