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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

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MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number 7425G
Device Problem Electromagnetic Compatibility Problem (2927)
Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Headache (1880); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Paresis (1998); Scar Tissue (2060); Vomiting (2144); Weakness (2145); Dizziness (2194); Discomfort (2330); Complaint, Ill-Defined (2331); Sweating (2444); Chest Tightness/Pressure (2463); Sleep Dysfunction (2517); No Code Available (3191)
Event Date 02/01/2001
Event Type  Injury  
Event Description
It was reported that the patient was admitted to the hospital on (b)(6) 2001 for chest pain and pressure radiating up into his neck that was unrelieved by nitroglycerin.Troponin was negative, ck/mb was negative, and ekg never changed.The patient reportedly had undergone multiple evaluations including coronary angiography in 1977 which was negative, numerous stress tests which have been negative, and normal electrocardiograms (ekg) and echocardiograms.It was noted that the event was not related to the device.Following labs were taken: blood pressure, pulse, respirations, cicu, chest x-ray, and temperature.No comment on any irregularities.The patient was placed on nitroglycerin and titrated to 30 mcg a minute with good pain relief after approximately an hour of drip.Heparin was infused as well.The patient was given 4 mg of morphine with final resolution of the pain.It was noted that the patient was titrated to pain relief via critical care drips.The following day, the patient complained of substernal chest pain and chest pressure with radiation to his arm.It was resolved with morphine sulfate.The patient had chest pain for several years, but ¿during the past few months¿ the pain was more ¿pressure-like and in the past it was more just pain.¿ labs and tests were unremarkable (electrocardiogram, ejection fraction, stress test, troponin, ck mb).Patient was discharged the following day on (b)(6) 2001.It was reported that the patient was admitted to the hospital on (b)(6) 2001 with complaints of ¿chest pressure #4 arm and chest.¿ patient had shortness of breath and diaphoresis and nausea.Patient called 911 after pain not resolving after three nitroglycerin.Patient reportedly responded to morphine.Patient reportedly had headaches and was taking antidepressant due to being ¿mildly depressed.¿ it was noted that nitroglycerin increased from 5 to 15 mcg/min and discomfort gone in 7-10 minutes.Electrocardiogram (ekg) showed ¿slight change in 1 box up in v1 and v2.¿ later that day, patient complained of ¿chest pressure #6 same as above.¿ two mg of intravenous (iv) morphine sulfate was given with relief.It was stated that the patient¿s history consisted of chest pain (non-cardiac per cardiology).It was noted that the plan was for the patient to discontinue heparin, see gastrointestinal for esophageal spasm, see psychologist for chronic pain/depression issues, and trial percocet for breakthrough pain, and increase neurontin.Troponin, electrolytes, creatinine, blood pressure, heart rate, respirations, and chest x-ray were normal.It was noted that it may be caused by esophageal spasm; it was reportedly not a coronary spasm, due to normal echo and ekg with severe chest pain in the past.It was noted that the patient had chronic chest pain syndrome and was taking fentanyl patch.It was stated it was not cardiac.The following day, it was reported that the patient was ¿lightheaded/sweating.¿ the patient took nitroglycerin four times and called 911.It was noted that nitro drip and chest pain were ¿negative.¿ it was noted that the patient had recurrent esophageal spasms and that the recurrent chest pain had an unknown etiology.It was considered that the chest pain was related to recurrent gastroesophageal reflux disease (gerd).Patient had stopped aciphex and restarted unknown number of weeks ago.The patient reportedly had 2 to 3 episodes of chest pain daily at home.Labs were normal (white blood cell, blood pressure, troponin, and hemoglobin).It was stated that the patient complained of episode of chest pain at 8 pm and was medicated with nitroglycerin sublingual.It was noted that ¿repeated after 5 minutes with stated relief in chest pain.¿ oxygen placed on at 2 liters.Blood pressure was 112/68 before chest pain and 108/68 after.It was stated that ¿teaching done for gall bladder, ultrasound¿ was scheduled for tomorrow.Two days after admission to the hospital, it was noted that depression had no longer been persistent.The patient was reportedly upset by bad news such as lay off.It was noted that he was on large doses of prednisone for asthma leading to cushing¿s syndrome.The patient was on fentanyl patch at 50 mcg/hour stating it was ¿fairly effective with occasional breakthrough pain.¿ it was noted that percocet was used for breakthrough pain.The patient¿s energy decreased and sleep was decreased but now better.Liver function test and egd was taken.It was noted that the plan was to increase antidepressant.The patient reportedly had an episode of chest pain at 7:30 pm.Patient was given nitroglycerin sublingual and had relief of chest pain.Blood pressure was 112/68 before nitroglycerin and 100/56 after intervention.No nausea was reported.Chest pain reoccurred at 11:15 pm and the patient was given nitroglycerin sublingual and there was ¿apparent relief.¿ three days after admission to the hospital, the patient had complaint of chest pain.It was noted that vital signs were stable and blood pressure was ¿okay.¿ it was noted that the chest pain occurred at 9:10 am and was rated a 3 out of a 1-10 scale.Chest pain was relieved after nitroglycerin and oxygen saturation 95%.It was noted that there was ¿still only 1 episode of emesis since device implant.¿ it was noted that bile was staining lower esophagus and stomach was retaining bile.Carafate slurry, ppi¿s bid, and small frequent meals were recommended.It was stated that the healthcare provider believed that the patient was getting esophageal spasm secondary to bile reflux.The healthcare provider (hcp) stated that issues were due to ¿continued severe gastroparesis.¿ the bile reflux can cause esophageal irritation and spasm and this can be mistaken for cardiac pain.Hcp was convinced that pain related to gastroparesis.Patient was on prevacid and had small frequent meals.Patient had dizziness at 10:30 am and chest pain at 11:45 am.Patient took nitroglycerin and oxygen saturation resulting in relief.Chest pain returned at 3:30 pm, where nitroglycerin was taken and oxygen saturation was applied.Later, patient complained of increased ¿neuritic¿ pain in feet, legs, and hands; patient received an additional 25 mcg/hour for fentanyl patch (50 mgc/hour total) and increased dose of percocet for 4-6 hours.Endoscopy was performed.Four days after admission to the hospital, patient complained of nausea at 9:00 am.Patient vomited 300 cc of undigested food.Later, patient had another 150 cc emesis undigested food.It was stated that the patient was feeling better but had emesis twice.It was noted that it could be that carafate slurry worsened symptoms or issues secondary to fentanyl or percocet.Pain was reportedly manageable.It was reported later that the patient was ¿doing better¿ and had no pain.Patient was discharged to go home at 2:20 pm without chest pain.Additional information stated that the event was not related to the device.Patient has had ¿some problems with insomnia recently¿ and was ¿tired.¿ it was noted that the patient showed marked delayed gastric emptying as well as manometry.Epigastric scars and multiple stria were noted.It was reported that the patient was admitted to the hospital on (b)(6) 2001 for substernal chest pain radiating to left chest and left arm.The patient became weak and diaphoretic and the pain did not resolve after four nitroglycerin.Labs and tests were unremarkable (white blood count, chest x-ray, ekg, coronary angiogram).It was noted that the patient was treated with morphine for pain relief.The patient reportedly had chest pain for 45 minutes to an hour.He became ¿weak and sweating,¿ had chest discomfort, and ¿didn¿t look well.¿ the patient reported coronary artery spasm.The patient was given sublingual nitroglycerin with resolution of his pain ad at the time a nitroglycerin patch was placed.The patient subsequently had return of the pain despite the nitroglycerin patch and was started on intravenous nitroglycerin with heparin and at that point had waxing and waning pain.Intravenous morphine sulfate was required for pain relief.The following day, the patient described a progressively worsening syndrome of mid and left-sided chest pressure becoming quite severe, at times brought on by activity but more recently occurring at rest.It was not unusual for the patient to experience this 3 to 4 times a day in the last week.Labs were unremarkable (blood pressure, pulse, chest x-ray, heart catheterization, respiratory rate, etc).It was stated that the event was not related to the device.It was noted that the device was causing artificial ¿spikes¿ on the ekg.The patient was discharged (b)(6) 2001.Additional information was requested.
 
Manufacturer Narrative
Concomitant medical products: product id 4351, serial# unknown, product type: lead; product id 4351, serial# unknown, product type: lead.(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Concomitant medical products: product id 4351, serial# (b)(4), product type: lead.Product id 4351, serial# (b)(4), product type: lead.Correction: manufacturing id 3007566237 is incorrect due to new device information found in device registration.Correct manufacturing id is 6000032.
 
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Brand Name
ENTERRA
Type of Device
INTESTINAL STIMULATOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
mdt sofamor danek puerto rico
barrio marianna rd 909, km0.4
humacao PR 00792 120
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key4003660
MDR Text Key16302876
Report Number6000032-2014-02255
Device Sequence Number1
Product Code LNQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2002
Device Model Number7425G
Device Catalogue Number7425G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2013
Date Device Manufactured09/11/2000
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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