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

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id :neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Orsagh-yentis, d.K., ryan, k., hurwitz, n., diefenbach, k.A., teich, s., mousa, h., bali, n., vaz, k., yacob, d., lorenzo, c.D., lu, p.L.Gastric electrical stimulation improves symptoms and need for supplemental nutrition in children with severe nausea and vomiting: a ten-year experience.Neurogastroenterol motil.2021.E14199 doi: 10.1111/nmo.14199 summary: gastric electrical stimulation (ges) is a promising therapy for children with severe nausea and vomiting, but information on long-term outcomes is limited.We sought to evaluate the long-term efficacy and safety of ges and to describe patient benefit and satisfaction.Using a prospective registry, we identified patients aged 21 years treated with ges at our institution between 2009 and 2019.Encounters were selected at baseline prior to ges and at follow-up at 1 month, 12 months, and the most recent visit.We compared symptoms, route of nutrition, and medication usage at baseline to follow-up timepoints.Factors associated with improvement were evaluated.We recorded complications and need for battery replacement.We contacted families to administer the glasgow children's benefit inventory (gcbi) and a parent satisfaction questionnaire.Eighty-five patients (68.2% female, median age 15.8 years) completed a trial of temporary ges due to severe nausea and vomiting.Seventy-seven (90.6%) had a positive response and underwent permanent stimulator placement.Use of tube feeding or parenteral nutrition (pn) decreased from 72.7% at baseline to 29.9% at the most recent follow-up (p <(><<)> 0.001).Higher baseline vomiting severity was associated with the ability to stop supplemental nutrition by 1 month (p <(><<)> 0.05).Fourteen patients (18.2%) had complications, primarily due to stimulator-associated discomfort, and 29 (37.7%) required battery replacement.Median gcbi was +52.1, indicating health-related benefit.Children with severe nausea and vomiting treated with ges experienced significant and durable improvement in symptom severity and their ability to tolerate oral nutrition.Reported events: fourteen patients (18.2%) had complications that necessitated further surgery.The most common reasons for surgery were patients¿ experiencing an uncomfortable shocking sensation or feeling that the ges was moving or malfunctioning in some regard.Of note, the electrodes of one patient (whose stimulator had been placed at an outside facility) eroded through the gastric wall.That patient's stimulator was removed and then permanently replaced at our institution.No specific device information provided.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12522856
• MDR Text Key: 273099157
• Report Number: 2182207-2021-01643
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2021
• 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