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

Model Number NEU_INS_STIMULATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Pontikos, a., jayakumar, p., rios perez, c., barker, h., hughes, m., yang, x., fraig, m., stocker, a., mcelmurray, l., pinkston, c., thomas, a.Gastric electrical stimulation has an effect on gastric interstitial cells of cajal (icc) that is associated with mast cells.Cureus.2020.12(11):e11458.Doi: 10.7759/cureus.11458 summary: gastric electrical stimulation (ges) is an emerging therapy for gastric motility disorders, showing improvement of gastroparesis related symptoms in previous studies.Interstitial cells of cajal (icc) and mast cells have been shown to have a relevant role in gastroparesis pathogenesis.However, the exact effects of ges in those cells is relatively unknown.Full thickness biopsies (ftbx) of 20 patients with refractory gastroparesis were obtained at the time of ges placement and repeated when the device was exchanged (mean of 22.5 months between biopsies).A patient reported outcomes survey was obtained during each office visit during this period.All biopsies were stained with cluster of differentiation 117 (cd117), s100, and mast cell tryptase antibodies and were analyzed.Half of the patients had a significant increase of icc during the repeated biopsy compared with baseline (p=0.01) and the other half had significant decrease in icc levels (p=0.006) but there was no noticeable difference in mast cells counts at baseline between groups.Mast cells analysis was performed in two different groups depending on icc change from the baseline biopsy (cd117 increase vs cd117 decrease).There was only a significant increase of mast cells count within the cd117 worsened icc group (p=0.007).No significant increase in the number of mast cells count seen in patients who received a ges may indicate an improvement in overall inflammation in patients with refractory gastroparesis after ges placement.Reported events: all patients had ftbx with ges placement for symptoms of gastroparesis uncontrolled with the conventional dietary and medication recommendation (the initial system) and then subsequently had another ftbx (the repeat system) when ges was replaced for technical reasons (usually symptoms of electrical shocking).

Manufacturer Narrative

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.

Event Description

There was no evidence of device or lead malfunction in any of these patients.Just needing reimplantation for clinical reasons.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11338603
• MDR Text Key: 232223305
• Report Number: 2182207-2021-00273
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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: 04/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention