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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Migration or Expulsion of Device (1395); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  Injury  

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name lead; product id neu_unknown_lead (lot: unknown); product type: 0200-lead; brand name lead; product id neu_ins_stimulator (serial: unknown); product type: 0197-implantable neurostimulator; g2: citation: authors: amit r.Persad, syed uzair ahmed, rosalie mercure-cyr, karen waterhouse, aleksander m.Vitali.Use of antibac terial envelopes for prevention of infection in neuromodulation implantable pulse generators.2023.Doi: 10.1227/ons.0000000000000367 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Section a references the majority of patients.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.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.

Event Description

Amit r.Persad, syed uzair ahmed, rosalie mercure-cyr, karen waterhouse, aleksander m.Vitali.Use of antibacterial envelopes for prevention of infection in neuromodulation implantable pulse generators.Concepts, innovations and techniques journal.Doi: 10.1227/ons.0000000000000367.Background: neuromodulation unit placement carries a historic infection rate as high as 12%.Treatment of such requires surgical removal and a long course of systemic antibiotics.Antibiotic-impregnated envelopes have been effective in preventing infection in implantable cardiac devices.At our center, 1 surgeon uses these envelopes with all implanted neuromodulation units.Objective: to assess the efficacy of antibacterial envelopes in prevention of infection in neuromodulation device placement.Methods: we conducted a retrospective cohort study of consecutive implantable pulse generator (ipg) unit implantation with an antibacterial envelope at a single center be tween october 2014 and december 2019.We collected demographic data, including postoperative infections, reoperations, and complications, associated with the ipgs.This cohort was then compared with a historical cohort of consecutive patients undergoing surgery before envelope usage (october 2007-april 2014).Results: in the pre-envelope cohort of 151 ipgs placed in 116 patients, there were 18 culture-confirmed infections (11.9%).In the antibacterial envelope cohort of 233 ipgs placed in 185 patients, there were 5 culture-confirmed infections (2.1%).The absolute risk reduction of the antibacterial envelope was 9.85% (95% ci 4.3%-15.4%, p.01).The number needed to treat was 10.1 (95% ci 6.5-23.1, p.01) envelopes to prevent 1 ipg infection.Conclusion: we saw a reduced rate of infections in the antibacterial envelope cohort.Although this is likely multifactorial, our results suggest a benefit of antibacterial envelopes on infection after neuromodulation surgery.Reported events: 1.It was reported that 4 patients had experienced infections of either the staphylococcus aureus, staphylococcus epidermidis or the staphylococcus lugdenensis bacteria.2.It was reported that 5 patients had surgical revisions to resolve a fractured lead.3.It was reported that 5 patients had surgical revisions to resolve lead migration.4.It was reported that 5 patients had surgical revisions to resolve lead mispositioning.5.It was reported that 5 patients had surgical revisions to resolve pain from their implanted system.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 18339910
• MDR Text Key: 330665126
• Report Number: 2182207-2023-02788
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2023

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_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/15/2023
• 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 Age: 69 YR
• Patient Sex: Female