MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id neu_ens_stimulator, product type external neurostimulator.Information references the main component of the system.Other relevant device(s) are: product id: neu_ens_stimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Kirss, j., jr., pinta, t., varpe, p., rautio, t., kairaluoma, m., hyöty, m., hurme, s., böckelman, c., kairaluoma, v., salmenkylä, s., victorzon, m.Outcomes of treatment of faecal incontinence with sacral nerve stimulation - a finnish multicentre study.Colorectal dis.2018.Doi: 10.1111/codi.14406 summary: the aim of this multicentre study is to report the results of sacral nerve stimulation (sns) treatment for faecal incontinence (fi) in (b)(6) and determine factors that could influence sns treatment outcomes.Method this is a national multicentre study, involving all patients tested for sns implantation in (b)(6) from 1999-2017.Data were collected retrospectively from electronic patient archives and analysed for possible effects on treatment outcome.Of the 432 patients tested for fi with sns, 365 were female.313 (72.5%) of the tested patients advanced to permanent stimulator implantation.A successful final treatment outcome, with subjective alleviation of fi, was reported by 59.3% of the patients at the end of follow-up (mean 2.4 years, range: 8 days- 13.3 years).Patients with obstetric sphincter injury and idiopathic fi had more permanent stimulator implantations compared with patients with iatrogenic injury (p=0.012).Male patients had significantly worse test phase outcomes compared with female patients (p <(><<)>0.001).Age did not influence treatment outcome (p=0.446).Subjective final success of sns treatment for fi was achieved in 59.3% of patients at a mean of 2.4 years.Gender and aetiology of fi influenced the test phase and final treatment outcome of sns treatment.Reported events: there were 65 patients (15.0%) who experienced a complication during sns testing and 19 patients (4.4%) who experienced a complication after permanent stimulator placement.The most frequent complication that arose during the test phase was operation site infection (in 26 cases).Operation site pain was the most common complication after permanent stimulator implantation.These are presented in figure 1.Of the patients who experienced a complication during sns testing, 62.5% had a successful test phase, whereas 74.6% of the patients with no complications during testing had a successful test phase (p=0.046).A complication after permanent stimulator implantation had a significant negative effect on the final treatment outcome (p<(><<)>0.001) (table 1).Of the patients who experienced a complication during the test phase, 25 (40.3%) required the removal of the electrode and cessation of the test.In 2 cases (3.2%) the electrode was replaced and testing was see attached literature article.

• Brand Name: NEU_INS_STIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; mansfield, MA 02048 ; 7635263920
• MDR Report Key: 8202346
• MDR Text Key: 131589253
• Report Number: 3007566237-2018-03724
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• 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): Other