BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2893172 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00038
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 10, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY BUT SHE WAS WORKING WITH HER DOCTOR OR MEDTRONIC REPRESENTATIVE. THE APPOINTMENT DATE WAS STATED AS (B)(6) 2013. THE PATIENT HAD TURNED THE DEVICE DOWN FROM 7 TO 4, UNITS UNCLEAR, BUT WAS STILL FEELING INTERNAL SHOCKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THE SURGEON TURN THEIR SETTING UP AND THE PATIENT BEGAN HAVING SEVERE CONTRACTIONS OR SHOCKS WITHIN THEIR ABDOMINAL AREA. THE PATIENT WENT BACK TO THE SURGEON TO REDUCE THE SETTING BACK TO THE ORIGINAL SETTINGS, HOWEVER THE PATIENT WAS STILL SUSTAINING SHOCKS AND CONTRACTIONS. IT WAS NOTED THE NAUSEA WAS BETTER WHEN THE PATIENT DIDN'T EAT BUT CONTINUED IF THEY ATE. IT WAS NOTED THE PATIENT WAS STILL ONLY EATING SOFT FOOD, SOUP AND CREAM OF WHEAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) NEVER WORKED FOR NAUSEA. THE PATIENT STATED THEY WOULD BE HAVING COLON SURGERY AND WERE CONSIDERING HAVING THE INS EXPLANTED SINCE IT WAS NOT WORKING. THE PATIENT NOTED THAT THE SURGERY WAS NOT RELATED TO THE INS AND STATED THEIR STOMACH AND COLON DON'T WORK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT'S THERAPY DID NOT HELP SINCE 2014. THE PATIENT HAD THEIR COLON REMOVED ON (B)(6) 2015 AND SINCE HAVING IT REMOVED, THEY HAD CONTRACTION OVER THE RIGHT SIDE OF THEIR STOMACH NEAR THE STOMA AND OSTOMY BAG. THE PATIENT HAD AN X-RAY DONE ON (B)(6) 2015 BECAUSE THEY WERE HAVING A LOT OF CONTRACTION AND PAIN IN THE ABDOMINAL AREA AND THE HEALTH CARE PROVIDER (HCP) THAT READ THE X-RAY SAID THE LEAD MOVED OR CHANGED. THE PATIENT WAS HAVING HORRIBLE CONTRACTIONS AND THE STIMULATOR WAS GRABBING ON TO WHATEVER ON THE ABDOMINAL AREA AND CONTRACTING LIKE CRAZY. THE PATIENT WOULD HAVE AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER ON (B)(6) 2015. THE DEVICE IS GOOD FOR ANOTHER 5 YEARS AND THE PATIENT WAS NERVOUS ABOUT HAVING IMPLANTED AS THEY HAD OTHER ISSUES AND DIDN'T WANT TO HAVE ANOTHER SURGERY. THE INDICATIONS FOR USE FOR THIS PATIENT WERE GASTRIC STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT SHE HAD PAIN AND DISCOMFORT WITH HER IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD TO FORCE HERSELF TO HAVE A BOWEL MOVEMENT, HAD TO TAKE LAXATIVES TO HAVE A BOWEL MOVEMENT, AND WAS CRAMPING OVER THE INS AFTER BOWEL MOVEMENTS. THIS HAD BEEN HAPPENING FOR SIX MONTHS PRIOR TO (B)(6) 2014. SHE ALSO EXPERIENCED PAIN UNDER THE INS, WHICH WAS RADIATING TO HER BACK, AND THE RADIATING PAIN STARTED THE NIGHT OF (B)(6) 2014. IT WAS LATER REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY AND SHE ALSO NOTED THAT SHE WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP; IT WAS UNCLEAR IF THE PATIENT STILL HAD CONCERNS OR NOT. THE PATIENT HAD FELT SHOCKING ON AND OFF SINCE GETTING THE DEVICE, BUT IN (B)(6) 2015 IT GOT MORE INTENSE AND WAS ALL OVER THE PLACE. SHE WAS ALSO GETTING SHOCKED IN STRANGE PLACES AND HER DEVICE WAS TURNED DOWN REALLY LOW. SHE GOT HER COLON REMOVED IN (B)(6) 2015 AND SINCE THEN, SHE HAD AN ILEOSTOMY BAG. SHE WAS DOWN TO ONLY (B)(6). SHE ALSO NOTED A LOSS OF THERAPY. THE PATIENT HAD ALSO BEEN HAVING STOMACH PROBLEMS, MORE NAUSEA, AND AN INCREASE IN STOMACH PAIN AND DISCOMFORT THAT WERE GETTING WORSE SINCE (B)(6) 2015. SHE ALSO HAD PAIN DIRECTLY BEHIND THE INS. ON (B)(6) 2015, SHE HAD AN ENDOSCOPY AND HER DOCTOR WAS NOT ABLE TO FIND THE ELECTRODES. THE DOCTOR HAD SEEN OTHER PATIENTS WITH ENTERRA DEVICES AND WAS ALWAYS ABLE TO SEE THE ELECTRODES DURING AN ENDOSCOPY. THE PATIENT'S DOCTOR RECOMMENDED THAT THE DEVICE BE REMOVED AND SHE HAD BEEN TRYING TO GET IT REMOVED. NO POTENTIAL EVENT CAUSE, INTERVENTIONS, OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1