MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Product id: 4351-35, serial# : (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 31-jan-2022, udi#: (b)(4) ; product id: 4351-35, serial/lot #: (b)(4), ubd: 31-jan-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (friend/family member, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient became unwell 48 hours prior to surgery with severe abdominal pains.Patient has long history of total gi failure.Patient had previously a enterra system that had worked well and reduced vomiting episodes.This system became infected as the lead had crossed the stomach lining and was subsequently removed.The new system was put back in (b)(6) 2021 and then reduced vomiting again from 20 times per day down to 1-2 times.Patient has been progressively been loosing weight over last 5 months despite increased tpn and no obvious sepsis.Patient has a reinsertion of jejunostomy feeding tube under fluoroscopy a month prior.Ct demonstrated large amount of free fluid but no free gas.They  did not improve with antibiotics and surgery was then advised.The enterra leads had "sentonised" completely through a loop of the proximal jejenum and the wires were found in the mesentery.The wire had distally eroded into a loop of more distal ileum and the wires were eroding into the proximal jejunum about 15cm from the dj flexure and doctor thinks this site is the cause of the peritonitis. patient is recovering and equipment is still implanted at this stage.The patient was taken to theatre to correct the peritonitis with washout and repair of any damage.This was when the erosion of the small bowel was seen and repaired.The leads were attached to the abdominal cavity to keep them away from the small bowel.

Event Description

Additional information received reported that effectively it was.A portion of the small bowel has herniated through a loop of the electrode wire and basically strangled itself on the wire.The surgeon felt this was a unusual complication of the procedure and said he would modify his implant technique to try and avoid this happening in the future.

Manufacturer Narrative

Concomitant medical product: product id 4351-35 serial# (b)(6) implanted: (b)(6) 2021 product type lead product id 4351-35 serial# (b)(6) implanted: (b)(6) 2021 product type lead 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.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 received reported that a portion of the small bowel has herniated through a loop of the electrode wire and basically strangled itself on the wire.The surgeon felt this was an unusual complication of the procedure and said he would modify his implant technique to try and avoid this happening in the future.

Manufacturer Narrative

Continuation of d10: product id 4351-35, serial# (b)(6), implanted: (b)(6) 2021, product type lead product id 4351-35, serial# (b)(6), implanted: (b)(6) 2021, product type lead.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12594925
• MDR Text Key: 275971338
• Report Number: 3004209178-2021-15045
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 10/07/2021; 01/11/2022
• Supplement Dates FDA Received: 10/15/2021; 01/20/2022
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female