MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_ENS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_ens_stimulator, lot# unknown, product type: external neurostimulator.Product id: neu_unknown_lead, lot# unknown, product type: lead.The main component of the system.Other relevant device(s) are: product id: neu_ens_stimulator, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Govaert, b., gemert, w.V., baeten, c.Predictive factors for subchronic test stimulation outcome in sacral nerve modulation for the treatment of fecal incontinence.Diseases of the colon and rectum volume 52: 4.2009.Summary/reported events: sacral nerve modulation is a well tolerated treatment for fecal incontinence.A unique advantage of sns treatment is the possibility to assess the feasibility of permanent stimulation by a temporary percutaneous nerve evaluation (pne) and subchronic test stimulation.Little is known about the predictive factors for a successful percutaneous pne and subchronic test stimulation.The purpose of this study is to discover possible predictive factors associated with pne and subchronic test outcome.We analysed data from all procedures performed in patients with fecal incontinence in the period from march 2000 till may 2007.Successful outcome was defined as >50% improvement of incontinence episodes in three weeks.Baseline demographics and anorectal investigations were analysed by logistic regression.Percutaneous nerve evaluations and subchronic test stimulation were performed in 245 patients (226 females).The univariate analysis showed an external sphincter (eas) defect to be significantly related to pne test failure (p=0.008).The size of the eas defect was not related to pne test failure.In the logistic regression model we found higher age (p=0.046), male gender (p=0.042), previous failed tests (p=0.002) and eas defects (p=0.005) to be predictors for failure.In the final model males with repeated procedures due to either lead dislocation or insufficient results in the first procedure, had a significantly lower probability on successful outcome than females (p=0.021).We have discovered several factors that can help predict the outcome of pne and subchronic test stimulation.Higher age, male gender, previously failed procedures and external sphincter defects on ultrasound show a statistically significant relation with pne and subchronic test stimulation outcome failure.

• Brand Name: NEU_ENS_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; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7619663
• MDR Text Key: 111679161
• Report Number: 3007566237-2018-01832
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• 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): Required Intervention