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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the article.If information is provided in the future, a supplemental report will be issued.

Event Description

Alabbad, a., abdo, e., hassouna, m., hassouna, m.Is radiation exposure during sacral neuromodulation within safety limits? can urol assoc j.2018.Doi: 10.5489/cuaj.5262 summary: the u.S.Food and drug administration (fda) approved sacral neuromodulation (snm) for intractable urge incontinence in 1997, urgenc y/ frequency syndrome, and non-obstructive urinary retention in 1999 for patients who have failed to respond or could not tolerate conservative treatment [1].In 2011, the fda approved snm for chronic fecal incontinence in patients who have failed or could not tolerate conservative treatment.Fluoroscopy guidance is recommended during permanent tined lead insertion in the s3 foramen.Before interstim system implantation, the patient underwent a clinical trial either by basic evaluation using temporary lead in the s3 foramen, (also referred to as peripheral nerve evaluation or pne) which is a simple, in-office procedure for external stimulation or by advanced evaluation using permeant tined lead in the s3 foramen under fluoroscopy guidance (also referred to as stage i) which is initiated through an outpatient procedure performed in a hospital or surgical center for external stimulation.Both evaluations are short-term, and the effects are reversible by removing the leads or turning off the device.Stage ii, is implantation of a subcutaneous implantable pulse generator (ipg).If pne was performed, fluoroscopic confirmation for the new permanent tined electrode placed in the s3 foramen is advised followed by the implantation of a subcutaneous ipg in the same sitting.Fluoroscopy utilizes x-rays, which are high energy ionizing radiations which causes cellular damage and even cell death.The amount of damage depends upon the total dose, duration of exposure, and the site of exposure.This damage can lead to biological effects, which may be stochastic (independent of the dosage received) or deterministic (dose-dependent effects) [2, 3].The major source of radiation is the c-arm, which is used to produce images for surgical guidance.The radiation exposure can be direct or indirect.Direct exposure is when the person is in the line of the radiation rays produced by the fluoroscopy machine.Indirect exposure occurs from scattered rays resulting from the interaction between the primary beam and the patient which disseminate in all directions [3, 4].The guidelines approved in 2009 by the society of interventional radiology (sir) and cardiovascular and interventional radiology society of europe (cirse) which identify patients with potential skin injuries requiring clinical follow-up (peak skin dose > 3 gy, air kerma at the patient entrance reference point >5 gy, kerma area product >500 gy·cm2, or fluoroscopy time >60 minutes)[5].Reported event: 14 patients (17%) experienced a revision due to unknown circumstances.No specific device information was provided.

• 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; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8170992
• MDR Text Key: 130613428
• Report Number: 3007566237-2018-03622
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970004
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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): Required Intervention