MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number NEU_INTERSTIM_INS

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Muscle Weakness (1967); Discomfort (2330); Numbness (2415); Constipation (3274)

Event Date 03/15/2024

Event Type  Injury  

Event Description

Dorfman, l., sigal, a., el-chammas, k., mansi, s., kaul, a.(2024).Sacral nerve stimulation effect on colonic motility in pediatric patients.Saudi j gastroenterol.2024;doi:10.4103/sjg.Sjg_407_23 summary: background: sacral nerve stimulation (sns) is a minimally invasive surgical procedure used to treat refractory constipation in children.While its efficacy in improving symptoms has been studied, its effect on colonic motor function remains unclear.This case series explores sns¿s impact on colonic motor function in pediatric patients with idiopathic constipation, using high-resolution colonic manometry (hrcm).Methods: four pediatric patients with chronic idiopathic constipation underwent sns placement for intractable symptoms and were subsequently evaluated via hrcm.Clinical characteristics, comorbidities, treatment regimens, and outcomes were reviewed.Hrcm was conducted during the sns-off and sns-on phases.The motility index (mi) was measured during the sns-off (fasting and postprandial) and sns-on phases.Results: four pediatric patients aged 8 to 21 years met the inclusion criteria.In three patients, sns-induced high-amplitude propagating contractions(hapcs) were noted, and in one patient, low-amplitude propagating contractions (lapcs) were noted.In one patient, propagating contractions were induced only when sns was turned on.Mi changes with sns-on were vari able among different patients with an increase in mi in two patients after turning sns on and a decrease in the other two compared with baseline.Adverse effects following sns placement remained minimal across all cases.Conclusion: this case series is the first to report sns effects on colonic motility evaluated by hrcm in pediatrics.We demonstrate that propagating colonic contractions are promptly induced when sns is turned on.Although the initial effects of sns on colonic motility were observable, additional investigation is necessary to comprehend the fundamental mechanisms and long-term effectiveness of sns in pediatric patients.  reported events: 1.Patient a: 21 year old female had subsequent worsening symptoms with muscle weakness, difficulty in evacuation, and numbness in a perianal area with normal electromyography.Moreover, patient experienced incisional tenderness and occasional pain from the device¿s wires.They also had battery movement for which a revision of the subcutaneous battery pocket was performed.2.Patient b: 8 year old female had no improvement but continued to have constipation with hard stool, requiring flushes every 3-4 days, and abdominal pain with urinary and fecal incontinence.Since they had a worsening of constipation symptoms in the follow up, their sacral nerve stimulator (sns) was removed.

Manufacturer Narrative

Continuation of d10: product id neu_interstim_ins lot# serial# unknown implanted: explanted: product type implantable neurostimulator section d information references the main component of the system.Other relevant device(s) are: product id: neu_interstim_ins, serial/lot #: unknown, ubd: unknown, udi#: unknown dorfman, l., sigal, a., el-chammas, k., mansi, s., kaul, a.(2024).Sacral nerve stimulation effect on colonic motility in pediatric patients.Saudi j gastroenterol.2024;doi:10.4103/sjg.Sjg_407_23 a.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19198306
• MDR Text Key: 341241467
• Report Number: 2182207-2024-02418
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• 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
• Patient Sex: Female