MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Nausea (1970); Swelling (2091); Vomiting (2144); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554); Abdominal Distention (2601)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient with an implantable neurostimulator (ins).It was reported that on (b)(6) 2014 the patient was seen for a follow-up visit and had not been seen since (b)(6) of 2013.It was noted that their device had been replaced in (b)(6) of 2014.In september, the patient reported bloating and abdominal pain during the visit.They stated they were not digesting food and every time they ate or drank they experienced severe bloating.They were concerned they were also not digesting their medications.The patient was concerned they were developing multiple food allergies.The patient also reported that they experienced shocking associated with the stimulator, they stated it was not comfortable and was usually associated with a positional change.An x-ray was done in december to check if the leads were in place, at this time the doctor reviewed the x-ray and confirmed the leads were in the correct position in the small bowel.It was noted the bowels were not moving well the patient was using linzess, which was noted to be helping a lot.The patient had gained 6 pounds since last seen in july.It was reported that at the time of report the patient was experiencing vomiting, nausea, anorexia/early satiety, bloating/distention, abdominal pain, constipation, diarrhea, infrequent urination.The physical examination notes stated that the patient's abdomen was soft and non-tender with positive bowel sounds.It was noted the abdomen was distended and there was a scar on the midline.It was noted their stimulator was on with a voltage of 7.5, pw 330, rate 28 cycling on 3 seconds and off 2 seconds; no changes were made.Additional information stated that their abdominal pain was better, they had been mostly dry heaving.They were able to keep water down and they were getting 240cc of tube feeds, which had increased from 80cc per day in the past.They stated they experienced severe bloating and a lot of times there was back pressure in their j-tube.At this time the patient's weight had increased 20 lbs, but the patient said it was mostly fluids and they required lasix.It was noted their stimulator was on with a voltage of 7.5, pw 330, rate 28 cycling on 3 seconds and off 2 seconds; no changes were made.The patient was seen again for follow-up on (b)(6) 2015.They complained of abdominal pain, bloating, constipation, diarrhea, nausea, and vomiting.It was noted they were last seen 2 months prior and they were complaining of increased pain and nausea.They were feeling hopeless because they had been doing well following a bowel resection, but had a reoccurrence of abdominal pain and said the pain was worse than they ever had.Swelling in the abdomen was noted and the patient stated that anytime they ate or took a tube feed they had significant swelling and distention.They reported drainage from their tube and not venting properly.The patient had another follow-up on (b)(6) 2016.Their chief complaints were listed as abdominal pain, bloating, diarrhea, nausea, urinary frequency, and vomiting.On (b)(6) 2020 another follow-up visit was documented.It was noted they were having blood sugar issues, but had seen their other healthcare provider regarding this.It was noted they had been running a fever, covid test culture and atb were negative, it was noted they did not have a port.No further complications were reported or anticipated.[relevant medical information: active problems: gi dysmotility, allergic rhinitis, bipolar disorder, constipation, depression, esop hageal reflux, gastric ulcer, gastroparesis (post-surgical), granulation tissue of site of gastrostomy, hypothyroidism, irritable bowel syndrome, migraine headache, peripheral neurostimulator, abdominal pain, afferent loop syndrome, bloating, dysuria, gi bleed, iron deficiency anemia, jejunostomy tube in situ, malnutrition, melena, psychosis, seasonal allergies, alleged sexual assault, arm edema, birth control, candidiasis, chronic diarrhea, chronic generalized pain disorder, complication of implanted device, controlled substance agreement, cough, cystocele with incomplete uterovaginal prolapse, delusions of parasitosis, dvt of upper extremity, gram negative bacteremia, scabies, intravenous line infection, skin wounds, neuropathic bladder, numbness, obsessive thinking, rectal prolapse, hiv screening, shortness of breath, social problems, somatic complaints, stress incontinence, systemic sclerosis, tia, vitamin d deficiency, weight loss, wheeze, yeast dermatitis, pregnancy past medical history: gastric and small bowel dysmotility, anxiety, gastric ulcer, allergic rhinitis, attention deficit disorder, bipolar disorder, congestive heart disease, depression, esophageal reflux, headache, hypotension, hypothyroidism, irritable bowel syndrome, peripheral neuropathy, seizure disorder, hyperinsulinism, elevated liver enzymes, pancreatic disorder, pneumonia, prior bowel issues, scoliosis, stroke syndrome, suicide attempt, dysuria, ear pain, pregnancy, uti surgical history: appendectomy, cholecystectomy, esophagogastric fundoplasty nissen fundoplication, gastric surgery, gastric surgery for morbid obesity, hernia repair, peripheral neurostimulator, small bowel resection, excision of lingual tonsils, tonsillectomy current medications: acidophilus, buspirone hcl, calcitriol, cetirizine hcl, clenpiq, concerta, creon, enoxaparin sodium, fentanyl, fluoxetine hcl, levothyroxine, linzess, lorazepam, magnesium, meloxicam, methylphnidate hcl, montelukast sodium, ocean nasal spray, omeprazole, pregabalin, silver sulfadiazine, triple omega, vitamin d, xifaxan, zenpep, zinc, zyrtec].

Manufacturer Narrative

D2: product code updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10158177
• MDR Text Key: 195532216
• Report Number: 2182207-2020-00355
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 64