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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 02/14/2020

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.Concomitant medical devices: product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator; product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator; product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator; product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Thompson, j.S., hewlett, a., lyden, e., scott, j.R., mcbride, c.Patient factors influence surgical options in gastroparesis.Am j surg.2020.Doi: 10.1016/j.Amjsurg.2020.02.022 summary: patient selection for the diverse surgical procedures for gastroparesis remains poorly defined.Our aim was to evaluate how patient factors have determined our surgical approach to gastroparesis.95 patients undergoing 105 surgical procedures for gastroparesis were reviewed.Patient factors were compared across six surgical procedures: gastric neurostimulator, pyloroplasty, neurostimulator plus pyloroplasty, sleeve gastrectomy, gastric bypass and gastrectomy.Global symptom severity was determined preoperatively and at last follow up.Results: there were significant differences in etiology, bmi and gastroesophageal reflux across the various operations.Patients undergoing pyloroplasty and gastrectomy; were more likely to have a postsurgical etiology.(p <.05) patients undergoing sleeve gastrectomy and gastric bypass were more likely to have bmi >35.(p <(> <<)>.05) those undergoing sleeve gastrectomy were less likely to have gastroesophageal reflux preoperatively.(p<.05) there was no difference in preoperative clinical stage across the procedures.Patient factors influence choice of procedure in the surgical treatment of gastroparesis.Etiology of gastroparesis, bmi >35 and gastroesophageal reflux are important determinants.Reported events: 1.4 (11%) patients that underwent ges alone underwent a subsequent pyloroplasty.2.Six devices had been replaced due to battery failure.3.Six devices were removed for complications and/or failure to improve symptoms.No specific device information provided.

Manufacturer Narrative

Continuation of d11: product id neu_ins_stimulator lot# unknown serial# implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# unknown serial# implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# unknown serial# implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# unknown serial# implanted: explanted: product type implantable neurostimulator 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.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10025460
• MDR Text Key: 197312884
• Report Number: 2182207-2020-00178
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention