MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3058

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

Patient Problems Unspecified Infection (1930); Urinary Retention (2119)

Event Date 02/11/2024

Event Type  Injury  

Event Description

Duelund-jakobsen, j., buntzen, s., lundby, l., laurberg, s., sorensen, m., rydningen, m.(2024).One-stage implant in sacral neuromodulation for faecal incontinence - short-term outcome from a prospective study.Colorectal dis.2024;doi:10.1111/codi.16936 summary: aim: sacral neuromodulation (snm) is approved for the treatment of faecal incontinence (fi) in a two-stage technique.With standardized implantation, approximately 90% of patients undergo successful stage i operation and proceed to a permanent implant (stage ii).The aim of this work was to explore the feasibility of snm as a one-stage procedure and report the 24-week efficacy.Method: this study included patients diagnosed with idiopathic fi or fi due to an ex[1]ternal anal sphincter defect =160° and one or more episodes of fi per week despite maximal conservative therapy.Patients were offered a one-stage procedure if a motor response of the external anal sphincter was achieved in three or more poles with at least one at =1.5 ma at lead placement.Patients were followed for 24 weeks.Their evaluation included the wexner/st mark's incontinence score, faecal incontinence quality of life score (fiqol), a visual analogue scale (vas) for assessing patient satisfaction and a bowel habit diary.Results: seventy-three patients with a median age of 60 years (interquartile range 50¿69 years) completed this prospective study.Episodes of fi were significantly reduced at the 24-week follow-up, from 13 (8¿23) at baseline to 2 (0¿5) (p-value = 0002).A =50% reduction in the number of fi episodes was achieved in 92% of participants.The wexner score improved significantly from 16 (14¿17) at baseline to 9 (5¿13) (p-value 0.001), , and the st mark's score improved significantly from 18 (16¿20) to 11 (7¿16) (p-value 0.001).All domains in the fiqol score and vas forpatient satisfaction improved significantly following the one-stage procedure.Conclusion: a one-stage implantation procedure is feasible in selected patients with fi, significantly improving continence, quality of life and patient satisfaction after 24 weeks of follow-up.Reported events: 1.   two patients developed an infection.One was of a deep infection on the fourth day after implantation so the pacemaker and electrode were therefore explanted.The other patient developed an infection during study follow-up who had the whole system explanted.2.   one patient experienced urinary retention.See attached literature article.

Manufacturer Narrative

Continuation of d10: product id 3058.Product type implantable neurostimulator section d information references the main component of the system.Other relevant device(s) are: product id: 3058, g2.Country denmark.Please note that this device was used in an off-label manner, as it was implanted for fecal incontinence.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.D.2.The device was used for an off label indication; see b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19198350
• MDR Text Key: 341238577
• Report Number: 2182207-2024-02419
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

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 Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/26/2024
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female