MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Sepsis (2067); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3093-33, lot#: v260716, implanted: (b)(6) 2009, explanted: (b)(6) 2014, product type: lead.Other relevant device(s) are: product id: 3093-33, serial/lot #: (b)(4), ubd: 21-may-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.  it was reported gastric stimulation.   it was reported that in 2014 the patient had to have the enterra device removed and that she was in the hospital for 10 weeks because of the issues she was having as the wires were wrapped around her small intestine and "chocked" it off.The device was removed and patient also mentions that they almost didn't remove the device because she was septic (confirmed this was related to the enterra device.No further complications were noted or anticipated.

Manufacturer Narrative

Supplemental submitted to correct event outcome attributed to adverse event.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.

Event Description

Additional information was received.The healthcare provider reported they didn't have access to the operation note, but provided an additional source of contact and historic medical records.It was noted the patient was complex with regard to post-surgical care and the system had been removed to resolve the wires being wrapped around the small intestines.It was further reported that on (b)(6) 2014 the patient was seen for a follow-up visit and had not been seen since (b)(6) 2013.It was reported that the patient had a small bowel stimulator placed in (b)(6) 2013, which was replaced in (b)(6) 2014 after malfunction.The gastric stimulator was removed.[relevant medical information: active problems: gi dysmotility, allergic rhinitis, bipolar disorder, constipation, depression, esophageal 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

D7: date is approximate.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.

Manufacturer Narrative

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.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.  it was reported gastric stimulation.   it was reported that in 2014 the patient had to have the enterra device removed and that she was in the hospital for 10 weeks because of the issues she was having as the wires were wrapped around her small intestine and "chocked" it off.The device was removed and patient also mentions that they almost didn't remove the device because she was septic (confirmed this was related to the enterra device.No further complications were noted or anticipated.

Manufacturer Narrative

Supplemental submitted to correct other relevant device(s) previously listed in h10.Other relevant device(s) are product id 4351-35 serial# (b)(6) ubd: 10-apr-2015, udi#: (b)(4) product id 4351-35 serial# (b)(6) ubd: 10-apr-2015, udi#: (b)(4) 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.

Manufacturer Narrative

H6: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been 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: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10021703
• MDR Text Key: 190036721
• Report Number: 3004209178-2020-08063
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 64