MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MESH NORTH HAVEN - SURGIPRO¿; MESH, SURGICAL, POLYMERIC

Model Number SPM35W

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Emotional Changes (1831); Foreign Body Reaction (1868); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371); Numbness (2415); Fibrosis (3167); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a left inguinal hernia repair.She had revision surgery 1 year and 4 months post-surgery.The patient underwent repair of umbilical hernia.The patient experienced nerve injections, neurectomy, chronic pain, numbness, limited mobility and revision.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced chronic pain, numbness, adhesions, limited mobility, recurrence, nerve damage, foreign body response, fibrotic tissue, neuropathy/neuropathic pain, and scar tissue.Post-operative patient treatment included nerve injections, neurectomy, revision, additional implants, nerve excision, post ileo-inguinal nerve root injection with no resolution of symptoms, and mesh explant.

Manufacturer Narrative

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

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced chronic pain, numbness, limited mobility, recurrence, nerve damage, fibrotic tissue, and scar tissue.Post-operative patient treatment included nerve injections, neurectomy, revision, additional implants, nerve excision and mesh explant.

Manufacturer Narrative

Additional information: b2, b5, d8, e1 (facility name, street 1, city, region, postal code), g1 (mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), g3, g4 (510k), h6 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

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, chronic pain, numbness, adhesions, limited mobility, recurrence, nerve damage, foreign body response, fibrotic tissue, neuropathy/neuropathic pain, and scar tissue.Post-operative patient treatment included nerve injections, neurectomy, revision, additional implants, nerve excision, post ileo-inguinal nerve root injection with no resolution of symptoms, and mesh explant.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced ovarian cyst, left inguinal pain, impingement of sensory nerve with probable neuroma, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, chronic pain, numbness, adhesions, limited mobility, recurrence, nerve damage, foreign body response, fibrotic tissue, neuropathy/neuropathic pain, and scar tissue.Post-operative patient treatment included nerve injections, neurectomy, revision, additional implants, nerve excision, post ileo-inguinal nerve root injection with no resolution of symptoms, and mesh explant.

Manufacturer Narrative

Additional info: h6 (patient codes, ime e2402: "impingement of sensory nerve, neuroma").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

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced neuralgia, ovarian cyst, left inguinal pain, impingement of sensory nerve with probable neuroma, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, chronic pain, numbness, adhesions, limited mobility, recurrence, nerve damage, foreign body response, fibrotic tissue, neuropathy/neuropathic pain, and scar tissue.Post-operative patient treatment included nerve injections, neurectomy, revision, additional implants, nerve excision, post ileo-inguinal nerve root injection with no resolution of symptoms, and mesh explant.

Manufacturer Narrative

Additional info: d4 (expiration date, lot #).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.

• Brand Name: MESH NORTH HAVEN - SURGIPRO¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 7032988
• MDR Text Key: 92060708
• Report Number: 1219930-2017-08765
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: SPM35W
• Device Catalogue Number: SPM35W
• Device Lot Number: A9B862
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 10/16/2019; 06/05/2019; 01/26/2022; 08/30/2023; 10/11/2023
• Supplement Dates FDA Received: 11/12/2019; 12/12/2019; 02/14/2022; 09/05/2023; 10/24/2023
• 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): Required Intervention; Other; Disability
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White