MAUDE Adverse Event Report: TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿; MESH, SURGICAL, POLYMERIC

Model Number IVS-02M

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

Patient Problems Cyst(s) (1800); Emotional Changes (1831); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Hypovolemia (2243); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Impaired Healing (2378); Prolapse (2475); Sleep Dysfunction (2517); Dysuria (2684); Constipation (3274); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of cystocele, enterocele, rectocele, urinary incontinence, urinary retention, uterine prolapse, and vaginal vault prolapse.It was reported that after implant, the patient experienced difficulties with bowel motions, rectocele, cystocele, vaginal infection, bladder infection, urinary incontinence, urinary retention, uterine prolapse, pelvic trauma, vaginal pain, vaginal discharge, hypotension, immune system disease, wound healing problems, feeling anxious, depressed, pain, impairment to activities, emotional changes, hypovolemia, bleeding, uti, labial cyst, atrophic vaginal tissue, dysuria, malodorous urine, urinary urgency, urinary frequency, inflammation, necrosis, infection, mucosal scarring.Post-operative patient treatment included medication, hospitalization, incontinence pad use, use of catheter, cystoscopy with urethroscopy, urodynamic testing, hysterectomy, transfusion of two units of blood, imaging required.

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.

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

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of cystocele, enterocele, rectocele, urinary incontinence, urinary retention, uterine prolapse, and vaginal vault prolapse.It was reported that after implant, the patient experienced difficulties with bowel motions, rectocele, cystocele, vaginal infection, bladder infection, urinary incontinence, urinary retention, uterine prolapse, pelvic trauma, vaginal pain, vaginal discharge, hypotension, immune system disease, wound healing problems, feeling anxious, depressed, pain, impairment to activities, emotional changes, hypovolemia, bleeding, uti, labial cyst, atrophic vaginal tissue, dysuria, malodorous urine, urinary urgency, urinary frequency, inflammation, necrosis, infection, not sleeping well, abdominal discomfort, and mucosal scarring.Post-operative patient treatment included medication, hospitalization, incontinence pad use, use of catheter, cystoscopy with urethroscopy, urodynamic testing, hysterectomy, transfusion of two units of blood, imaging required.Relevant tests/laboratory data: (b)(6) 2009: serum crp 39.3, indicating inflammation, necrosis or infection.Hemoglobin 10.5 23 aug 2019: urodynamic testing showed poor bladder sensation and contraction.Tight tapering of distal urethra with voiding, likely the site of her sling.Imaging showed hyper-suspended urethra with mucosal scarring.

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.

• Brand Name: MESH BALLYMONEY - IVS TUNNELLER¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYCO HEALTHCARE UK MANF. LTD; 20 garryduff road ; ballymoney,at BT53 7AP ; UK BT53 7AP
• Manufacturer (Section G): TYCO HEALTHCARE UK MANF. LTD; 20 garryduff road ; ballymoney,at BT53 7AP ; UK BT53 7AP
• Manufacturer Contact: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14459173
• MDR Text Key: 292198231
• Report Number: 6000141-2022-00014
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2013
• Device Model Number: IVS-02M
• Device Catalogue Number: IVS-02M
• Device Lot Number: 08B288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• Date Device Manufactured: 02/28/2008
• 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; Hospitalization; Disability
• Patient Sex: Female
• Patient Weight: 94 KG