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

Model Number NEU_INTERSTIM_INS

Device Problems Break (1069); Migration or Expulsion of Device (1395); Battery Problem (2885); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Skin Erosion (2075); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_interstim_ins lot#, unknown, serial#, implanted, explanted, product type implantable neurostimulator.Product id neu_unknown_lead, lot# unknown, serial#, implanted, explanted, product type lead.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_interstim_ins, serial/lot #: unknown, ubd: unknown, udi#: unknown; product id: neu_unknown_lead, serial/lot #: unknown, ubd: unknown, udi#: unknown.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.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Chartier-kastler, e., le normand, l., ruffion, a., saussine, c., et al (2023).Five-year results from the prospective, multicenter, observational sounds study of patients with overactive bladder treated with the interstim system for sacral neuromodulation.European urology focus.2405-4569.Https://doi.Org/10.1016/j.Euf.2023.03.008 summary: background: although sacral neuromodulation (snm) for overactive bladder (oab) is an established therapy, there is a lack of high-quality, long-term data on real-life practice.Objective: to report on real-life therapeutic effectiveness, quality of life (qol), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up.Design, setting, and participants: a total of 291 oab patients were enrolled at 25 french sites according to local standard of care.Sacral neuromodulation with interstim therapy for intractable lower urinary tract dysfunctions (sounds) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted.Outcome measurements and statistical analysis: over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annu ally thereafter.Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo.Results and limitations: the mean number of daily leaks in urinary urge incontinence (ui) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p <(><<)> 0.001).Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p <(><<)> 0.05).Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement ui patients, and 68% (39/57) and 67% (10/15) of ui patients were categorized as therapy responders by showing a >50% improvement in leaks.Disease severity (urinary symptom profile domain 2), numeric rating scale¿based symptom bother, and disease-specific qol (ditrovie) improved significantly in both groups at all visits (p <(><<)> 0.001).Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (clavien-dindo grade i and ii).Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients.Conclusions: sounds demonstrates the sustained effectiveness and qol improvements of snm in oab patients after 5 yr in real-world conditions while maintaining an accept able safety profile consistent with literature.Patient summary: this study confirmed that french overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.Reported events: 1.38 patients who had explants for therapy ineffectiveness, infection, pain, skin erosion, other.Four of the 38 events were resolved without sequelae.2.89 patient who had revisions for battery depletion, electrode migration, fracture, elevated impedance, infection, pain.

• Brand Name: INTERSTIM
• 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: 16975523
• MDR Text Key: 315829610
• Report Number: 2182207-2023-00920
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970004
• 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: 05/22/2023

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 Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/22/2023
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention