BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3222482 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11648
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    September 19, 2012
    Report Date
    November 21, 2020
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CODE REMOVED AS IT NO LONGER APPLIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTER WAS UP "ALL NIGHT LONG LAST NIGHT WITH HER (THE PATIENT) AND SHE IS IN THE HOSPITAL NOW". THE PATIENT WAS HAVING A LOT OF PAIN AND THE DEVICE HAD HELPED HER NOT VOMIT AS MUCH AS SHE DID BEFORE. THE PATIENT USED TO GO TO THE HOSPITAL EVERY OTHER WEEK BEFORE THE INS WAS IMPLANTED. WHEN THE INS WAS IMPLANTED, IT WAS PUT RIGHT AGAINST HER RIBCAGE "AND IT RUBS HARD AGAINST IT AND IT AGITATES IT, AND NOW SHE IS HAVING PAIN ON THE LOWER ABDOMEN". THEY WERE ASKING ABOUT REMOVING INS AND REPLACING IT IN A DIFFERENT LOCATION. THEY WERE INTERESTED IN A SECOND OPINION. IT WAS LATER REPORTED ON (B)(6) 2013 THAT PNEUMONIA WAS NOTED. THE PATIENT WAS STILL VOMITING AND WAS DOWN TO (B)(6) POUNDS. THE PATIENT HAD PAIN ON THE INCISION SITE, JUST BELOW THE RIBS. THIS STARTED HAPPENING 2 WEEKS AGO, AND THEY HAD SO MUCH PAIN THAT SHE HAD TO GO TO THE ER. THE PATIENT WOULD GET A LOT OF PAIN NEAR HER STIMULATOR BUT DOCTOR DIDN'T FIND ANY INFECTIONS. THE PATIENT WAS IN HOSPITAL FOR 2 WEEKS. THE PATIENT HAD NO FALLS OR TRAUMA. IT WAS NOTED THAT THEY WANT THE INS TAKEN OUT AND REPLACED IN ANOTHER POSITION AND THE HEALTHCARE PROVIDER DID NOT WANT TO DO THAT. THEY HAD BEEN SPEAKING WITH A DOCTOR AT THE (B)(6) CLINIC, WHO WAS GOING TO PUT IN A J TUBE AND IMPLANT THE PATIENT, BUT THEY COULDN'T STAY IN (B)(6) FOR THE IMPLANT AND HAD TO RETURN HOME. WITHOUT THE J TUBE, THE PATIENT WAS MALNOURISHED AND WAS ON TPN TUBE FEEDING. BEING MALNOURISHED CAUSED THE PATIENT ADEMA AND PNEUMONIA. THEY WERE PLANNING TO FOLLOW UP WITH ADDITIONAL PHYSICIANS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT SHE WAS STILL HAVING THE ISSUES THAT SHE PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323559 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R "SEE H10...."