MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

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.Concomitant medical products: product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, product id: neu_unknown_lead, serial/lot #: unknown, product id: neu_unknown_lead, serial/lot #: unknown, 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

De meyere, c., nuytens, f., parmentier, i., d'hondt, m.Five-year single center experience of sacral neuromodulation for isolated fecal incontinence or fecal incontinence combined with low anterior resection syndrome.Tech coloproctol.2020.Doi: 10.1007/s10151-020-02245-2 summary: sacral neuromodulation (snm) has proven to be a safe and effective treatment for fecal incontinence (fi).For low anterior resection syndrome (lars), however, snm efficacy is still poorly documented.The primary aim of this study was to report on efficacy of snm therapy for patients with isolated fi or lars.Furthermore, we evaluated the safety of the procedure and the relevance of adequate follow-up.A retrospective analysis was performed upon a prospectively maintained database of all patients who underwent snm therapy for isolated fi or lars between january 2014 and january 2019.The wexner and lars scores were evaluated at baseline, during test phase, after definitive implantation and annually during follow-up.Treatment success was defined as at least 50% improvement of the wexner score or a reduction to minor or no lars.Out of 89 patients with isolated fi or lars who had a snm test phase, 62 patients were eligible for implantation of the permanent snm device.At baseline, 3 weeks, and 1, 2, 3, 4 and 5 years after definitive implantation the median wexner score of all patients was 18, 2, 4.5, 5, 5, 4 and 4.5, respectively, and 18, 4, 5.5, 5, 4, 3 and 4, respectively, for patients with fi and lars.Patients with lars more frequently required changes in program settings.Snm therapy is a safe and effective treatment for patients with isolated fi and patients with fi and lars.Adequate follow-up is essential to ens ure long-term effectivity, especially for lars patients.Reported events: in nine patients (14.5%), surgical re-intervention was required due to a complication; postoperative infection occurred in two patients (3.2%), for which the devices were explanted.In one patient, a new snm device was implanted 2 months after resolution of the infection.The other patient refused reimplantation although complete resolution of the wound infection was obtained.A lead revision was caused by a traumatic event in one patient.A lead revision was caused by a rotation of the device in two patients, which caused a fracture of the tined lead.In three patients (4.8%), the device was repositioned due to spontaneous rotation of the device and/or pain at the implant site.One patient required re-intervention because of wound dehiscence with exposition of the lead.No specific device information provided.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 10817730
• MDR Text Key: 217926437
• Report Number: 2182207-2020-01251
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/10/2020
• 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