BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3190418 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10896
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 4, 2013
    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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE LAST TIME THE PATIENT WAS SEEN BY THEM WAS ON (B)(6) 2013 FOR NORMAL DEPLETION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO HIGH SETTINGS (CONSTANT USAGE ¿ 24 HOURS). THERE WAS NO DOCUMENTATION IN THE PATIENT RECORDS OF ANY TOPYE OF OBSTRUCTION. THE HCP NOTED THAT IF THE INS HAD CAUSED THE OBSTRUCTION IT WOULD HAVE BEEN DOCUMENTED. THE PATIENT HAD NOT BEEN SEEN SINCE THE REPLACEMENT SURGERY AND THERE HAD BEEN NO REPORTED POST-OPERATIVE COMPLAINTS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. IT WAS STATED THAT THE HEALTH CARE PROVIDER (HCP) TOLD THE PATIENT THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS "BROKEN". IT WAS STATED THAT THE PATIENT BEEN IN PAIN FOR THE PAST THREE MONTHS FROM "OBSTRUCTIONS, VOMITING AND DRY HEAVING".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT HAD NO STIMULATION SENSATION. IT WAS STATED THE DEVICE WAS ¿BROKEN¿ AND HAD IT REPLACED ON (B)(6) 2013. IT WAS NOTED THE PATIENT THOUGHT THE HCP LEFT THE LEADS IN PLACE AND ONLY REMOVED THE INS. IT WAS STATED THE PATIENT HAD PAIN ONE WEEK AFTER SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOKE UP IN PAIN ON THE DAY OF THE REPORT BECAUSE HER STOMACH WAS SEIZING. THE PATIENT WAS SURE THAT SHE HAD A PARTIAL OBSTRUCTION BETWEEN HER STOMACH AND SMALL INTESTINE BECAUSE OF HER SYMPTOMS. THE PATIENT WAS STILL TAKING ¿MIRILAX¿ AND THE DEVICE HAD NOT BEEN WORKING ¿AS WELL AS SHE EXPECTED.¿ THE PATIENT FELT SHE NEEDED STIMULATION RATE INCREASED AND HAD BEEN MISERABLE FOR THE ¿LAST COUPLE MONTHS.¿ THE PATIENT GOT BILE IN HER MOUTH AND BACK OF HER THROAT AND WAS UNABLE TO GET THE DRY HEAVING TO STOP. IT WAS VERY TIRING AND PAINFUL AND THEN THE BILE SAT IN HER STOMACH. ¿LAST NIGHT IT FELT WORSE¿ AND ¿THIS MORNING THE PATIENT COULD HARDLY WALK.¿ THE PATIENT TOOK ANOTHER DOSE OF ATIVAN BUT THAT DID NOT HELP. THE PATIENT WAS IN A CAR ACCIDENT ON (B)(6) 2013 AND HAD AN ELBOW SURGERY ON (B)(6) 2013 BUT DID NOT NOTICE A CHANGE IN HER THERAPY. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) WAS UNABLE TO SEE HER UNTIL (B)(6) 2013. THREE DAYS LATER, IT WAS CONFIRMED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH HER HCP FOR (B)(6) 2013. THE PATIENT WAS TOLD SHE ¿COULD COME TO THE OFFICE AND SIT ALL DAY AND BE WORKED IN BUT SHE WAS TOO SICK TO THE LEAVE THE HOUSE.¿ THE PATIENT WAS NOT SURE IF THE THERAPY WAS WORKING FOR HER AND WAS AFRAID TO TURN THE THERAPY OFF. THE PATIENT STATED THAT SHE STILL HAD A PARTIAL OBSTRUCTION THAT SHE HAD FOR ¿QUITE A WHILE¿ AND WAS WAITING FOR IT ¿TO GO LOOSE.¿ THE PATIENT ALSO NOTED THAT THE DEVICE ¿STUCK OUT.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT FELT PAIN IN THE "UPPER GASTRIC WHERE HER ABDOMEN SWELLS". IT WAS REPORTED THAT THE PATIENT'S FOOD WAS "NOT GOING THROUGH CORRECTLY CAUSING NAUSEA AND DRY HEAVING". IT WAS REPORTED THAT THE PATIENT HAD A "PARTIAL OBSTRUCTION" WHICH "OCCURRED CONSTANTLY". IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. IT WAS STATED THAT THIS STARTED "ABOUT THREE MONTHS AGO OUT OF THE BLUE". IT WAS STATED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT SAW HER DOCTOR THE PREVIOUS WEEK BECAUSE OF HER PAIN AND SYMPTOMS. THE DOCTOR CHECKED THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS AND "IT APPEARED THAT IT DID NOT REGISTER AND IT WAS NOT WORKING ". IT WAS NOT KNOWN WHAT THE REASON WAS. IT WAS REPORTED THAT "THEY COULD NOT REPLACE FOR ONE MONTH BECAUSE OF A HOLD". IT WAS REPORTED THAT THE PATIENT SAW A GASTROINTESTINAL DOCTOR AFTER THAT APPOINTMENT AND WAS ADMITTED TO THE HOSPITAL AND HAS BEEN THERE EVER SINCE. ADDITIONAL INFORMATION RECEIVED ABOUT ONE WEEK LATER REPORTED THAT THE PATIENT WAS EXPERIENCING "MISERABLE" FEELINGS OVER THE LAST TWO MONTHS BECAUSE THE DEVICE WAS "BROKEN AND COULD NOT BE REPROGRAMMED". IT WAS STATED THAT THE PATIENT'S HOSPITAL HAD "PUT A BLOCK ON ALL ENTERRA SURGERIES", BUT NO ONE TOLD THE PATIENT WHY. IT WAS REPORTED THAT THE PATIENT WAS "VERY SICK AND VERY UNCOMFORTABLE". IT WAS REPORTED THAT THE PATIENT COULD NOT "KEEP THE PAIN AND NAUSEA AWAY WITH HER AT-HOME MEDICATION". IT WAS FURTHER NOTED THAT THE HOSPITAL HAD PUT A HOLD ON NEW OR REPLACEMENT ENTERRA DEVICES DUE TO A "CLERICAL ISSUE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289815 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| O