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

Model Number NEU_INTERSTIM_INS

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abscess (1690); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product id: unknown lead, product type lead, product id neu_interstim_ins, product type implantable neurostimulator, product id neu_unknown_lead, product type lead.Device information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead; product id: neu_interstim_ins; product id: neu_unknown_lead.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that event 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.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

Culmone, a., speciale, p., guastella, e., et al.(2022).Sacral neuromodulation for refractory lower urinary tract dysfunctions: a s ingle-center retrospective cohort study.Italian journal of gynæcology & obstetrics.December 2022 - vol.34 - n.4 - quarterly - issn 2385 ¿ 0868.Doi: 10.36129/jog.2022.61 summary: the objective is sacral neuromodulation (snm) is a technique that electrically stimulates the third sacral spinal nerve root to modulate a neural pathway.In this study, we present our 7-years¿ experience outcomes and complications of snm in lower urinary tract dysfunctions.The materials and methods use is that we performed a single-center retrospective cohort study of all patients who underwent interstim medtronic snm device implantation for lower urinary tract dysfunction.All procedures were performed between january 2014 and november 2021 in the urogynecologycal center of villa sofia hospital in palermo by a single expert team.We included 68 patients with refractory lower urinary tract dysfunction who did not adequately respond to primary therapeutical strategies.The results were that we observed a reduction rate of catheterization from a mean of 4.05 to 1.22.In addition, the amount of post-voidal residual decreased from a mean of 520 ml to 187 ml.Among the 41 women in the overactive bladder group, only 36 were included in the follow-up; 24 of the 36 patients (66.6%) had no episodes of leaks; the remaining patients (33.4%) had a significant reduction of leaks.We also recorded a significant reduction in urinary frequency: voids per day decreased from 16.1 at baseline to 6.1.Among the 7 women with bps, only 5 patients (71.42%) completed the follow-up protocol.They reported satisfaction from the treatment: no patients chronically used pain drugs, and only 1 used occasionally painkillers.In conclusion, snm treatment has been found as a potential effective and feasible option for urogynecologycal disorders.  reported event: 1.       two female patients had wound abscess.The lead was removed and not reimplanted due to inefficacy.2.       three female patients had the device removed due to inefficacy.3.       one female patient had a migration of the lead that occurred so another one was reimplanted.See attached literature article.

• 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: 16250588
• MDR Text Key: 308234888
• Report Number: 2182207-2023-00153
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/26/2023

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?: No
• 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: 01/25/2023
• Initial Date FDA Received: 01/26/2023
• 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
• Patient Sex: Female