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

Model Number NEU_INTERSTIM_INS

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429); Battery Problem (2885); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Seroma (2069); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Slauf, p., voboril, r.(2021).Sacral neuromodulation in fecal incontinence treatment ¿ 10 years of experience and long-term results from a specialized center.Rozhl chir.2021;100:475-483.Doi:10.33699/pis.2021.100.10.475¿483 summary: introduction: sacral neuromodulation/sacral nerve stimulation (snm/sns) has become the most successful method for treatment of faecal incontinence (fi) in the last 10 years.The high efficiency of snm is based on the electrical stimulation of the external anal sphincter and moreover the mechanism of action of sns can be explained by the modulation of somatovisceral reflexes and perceptions of afferent information.Therefore the mechanism of action is more complex in contrast to other methods of treatment.In the czech republic, the snm was implemented for the first time in 2010 with the financial support of the iga grant of the ministry of health of the czech republic.Since 2018, two specialized centres for the treatment of fi using the snm method have been established in the czech republic.Methods: in the years 2010-2020, 35 patients were indicated for snm.The ratio of women to men was 34:1.The mean age at implantation was 62 years (range 46-75).Most patients were in the 6th and 7th decade.Two diagnostic procedures were performed in all patients, percutaneous evaluation of the s2-s4 sacral nerves, implantation of the medtronic 3889 28cm stimulation tined lead electrode and its connection to an external stimulator and subsequent subchronic stimulation for 2-4 weeks.The criteria for permanent neurostimulator implantation were a minimum 50% reduction in the number of fi episodes per week or a 50% reduction in incontinence score.Patients were then implanted with a medtronic interstim ii 3058 permanent neurostimulator.Results: a permanent neurostimulator was implanted in 33 of 35 patients (94%).No patient died.The complication rate was 11.4%.In 2 patients it was an infectious complication.In one patient malposition of the stimulator occurred after falling down and in one patient we observed lead breakage with subsequent malfunction of the stimulator after falling down.All complications were successfully resolved by reoperation.The long-term effect of snm was evaluated in the group of the first 15 implanted patients from 2010-2011.Of these, 9 patients were available, in whom a new neurostimulator was reimplanted due to loss of battery power in 2018-2020.The mean length of follow-up was 112 months (99-124).The mean number of fi episodes per week was 1.9 (0-13) after neurostimulator implantation compared to 13.6 (3-25) before implantation.The cleveland clinic incontinence score (ccis) was 8.3 (3-16) after neurostimulator implantation compared to ccis 18.8 (15-20) before implantation.Both fi episode counts and ccis scores were significantly lower (p<(><<)>0.05).According to pp (per protocol) analysis, in 64.3% of patients at least 50% improvement of continence or reduction of fi episodes persists after 8-10 years in comparison with the condition before primary implantation; full continence was achieved in 4 patients (28.6%).><(><<)>0.05).According to pp (per protocol) analysis, in 64.3% of patients at least 50% improvement of continence or reduction of fi episodes persists after 8-10 years in comparison with the condition before primary implantation, full continence was achieved in 4 patients (28.6%).Conclusion: sacral neuromodulation is an effective and safe minimally invasive method for the treatment of severe faecal incontinence.A beneficial long[1]term effect is observed in more than half of the patients.Successful outcomes of snm depend on careful selection of patients, precise electrode placement technique and experience of the specialized centre.Reported events: 1.One patient was observed with postoperative local infection.The seroma was in the surgical wound of an obese patient after implantation of the stimulation electrode which was discovered later during the subsequent second stage sns operation.This was not considered ta reason to postpone the stimulator implantation.The seroma was evacuated, the wound was cleaned, the patient received antibiotic prophylaxis, and the permanent neurostimulator was additionally coated in garamycin foam.The surgical wound healed without any further complication.  2.One patient developed postoperative local infection after implantation of the neurostimulator despite antibiotic prophylaxis.A s eroma developed which was repeatedly evacuated under strictly sterile conditions but no effect, broad spectrum antibiotics were administered according to sensitivity, but without effect.This gradually led to an abscess of the surgical wound.A revision was surger y was performed.Reoperation was performed 5 weeks after implantation of the stimulator.During operation, it was found turbid effusion in the area of the subcutaneous pocket with the implanted stimulator, which was surrounded by a fibrous capsule of sorts.The st imulator was disconnected from the electrode and removed from the surgical wound and soaked in disinfectant solution so that fluid would not reach the electrode connection area.The fibrous capsule was extirpated, and they extirpated the skin and subcutaneous tissue in the entire area of the wound.Following disinfection of the surgical field with undiluted betadine solution, the electrode was reconnected to the neurostimulator, which was also coated in garamycin foam.As a staphylococcus infection (staphyl.Aureus) had been demonstrated already before surgery, the antibiotics were administered for 7 more days.The surgical wound now healed per primam and the neurostimulator was fully functional.3.One patient experienced two falls about 6 months after implantation of the ins, the ins gradually became malpositioned in the subcutaneous tissue, rotating 90 degrees and pressing its edge against the skin.This caused irritation and swelling of the skin and severe restrictive pain to the patient, although the stimulator was not impaired.Reoperation done to adjust ins back into original pocket position.The surgical wound healed without complications, and patient is free of discomfort and ins is functional.4.One patient had a fall, and there were complications on the side of the implanted ins about 6 months after implantation which led to complete loss of its function and relapse of complete incontinence.Patient did not feel stimulation in anus at all, except on occasional propagation to the left lower limb even at minimal stimulation intensity.During follow-up, high impedance over 4k was found indicating the likelihood of disruption or kinking of the stimulation electrode.This suspicion was confirmed through x-ray where the electrode position was found in lateral image to be deeper in the presacral region and bent 60 degrees just above the four terminal active electrodes while a kink was located at the point of the proximal radiocontrast mark of the electrode at the level of the sacral fascia.The electrode was explanted and new electrode implanted on the opposite side.The wound healed and the ins function was fully restored.5.10 patient had battery discharge.Of the 10, nine patients undergone reimplantation of a new ins.The remaining one patient underwent an explanation of the ins and lead without complication.6.Three patient underwent explanation of device.One patient¿s stimulation effect gradually deteriorated about one year after impl antation.Other two patient were due to being unresponsive to conservative treatment.

Manufacturer Narrative

Concomitant medical product id neu_interstim_ins, lot# unknown, product type implantable neurostimulator.Product id neu_interstim_ins, lot# unknown, product type implantable neurostimulator.Product id neu_unknown_lead, lot# unknown, product type lead.Product id neu_interstim_ins, lot# unknown, product type implantable neurostimulator.Product id neu_interstim_ins, lot# unknown, product type implantable neurostimulator.Device 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 product id: neu_interstim_ins, serial/lot #: unknown, ubd: unknown, udi#: unknown product id: neu_unknown_lead, serial/lot #: unknown, ubd: unknown, udi#: unknown product id: neu_interstim_ins, serial/lot #: unknown, ubd: unknown, udi#: unknown product id: neu_interstim_ins, serial/lot #: unknown, ubd: unknown, udi#: unknown.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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 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: 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: 16315068
• MDR Text Key: 308976424
• Report Number: 2182207-2023-00229
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2023

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_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/07/2023
• 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