MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_ENS_STIMULATOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Literature citation: hasanin m, amin o, hassan h, kedar a, griswold m, abell tl.Temporary gastric stimulation in patients with gastroparesis symptoms: low-resolution mapping multiple versus single mucosal lead electrograms.Gastroenterology research.2019;12(2):60-66.Doi: 10.14740/gr1127.Age: this value is the average age of the patients reported in the article, as specific patients could not be identified.Sex: this value reflects the sex of the majority of the patients reported in the article, as specific patients could not be identified.Date of event: please note this date is based off of the manuscript acceptance date as the specific event date was not provided in the published literature.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant medical products: product id: neu_unknown_lead, product type: lead.Product id: neu_ens_stimulator, product type: external neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot#: unknown, ubd: asku, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Article summary: the authors hypothesized that using two leads would vary from a single lead by providing greater insight of gastric electrical wave propagation, through differences in measured frequency, amplitude, and frequency over amplitude ratio.They additionally hypothesized that a significant reduction in symptomatic vomiting score was highly predictive in a single lead temporary gastric electrical stimulation.It was ultimately concluded that compared to the use of single point electrodes, the use of two low-resolution electrodes allowed recording gastric electrical wave propagation with greater detail.Low resolution recording appeared to be superior to single point recordings, while awaiting practical high-resolution recordings.Reported event: it was reported that lead dislodgement was observed in some patients.It was noted this was the only complication observed during the study.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8679006
• MDR Text Key: 195316017
• Report Number: 3007566237-2019-01251
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR