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

Model Number NEU_INS_STIMULATOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Stroke/CVA (1770); Sepsis (2067); Post Operative Wound Infection (2446); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

Event Type  Injury  

Event Description

Abstract/summary background: indications for deep brain stimulation (dbs) are rapidly growing within functional neurosurgery.The objective of this study was to characterize national trends in demographics and complications across distinct populations of dbs patients.Methods: we identified patients from the 2008¿2018 american college of surgeons national surgical quality improvement program (acs nsqip) participant use data file (puf) who underwent an implantation or revision procedure for dbs.Summary statistics for postoperative infection rate, noninfectious complication rate, total hospital length of stay, discharge disposition, mortality, reoperation or readmission, and time from operation to readmission were obtained.Patients were categorized by diagnosis for dbs treatment.Outcomes for each diagnosis group were compared to outcomes for the total study population.Results: dbs patients who underwent primary implantation procedures had low rates of postoperative infections (1.2%), noninfectious complications (0.8%), and mortality (0.1%) and a high likelihood of discharge home (97.6%).In addition, a large percentage of patients presented for revision or removal of neurostimulators (34.2% of cases) or treatment of long-term hardware infection (4.5%).Compared with patients with other diagnoses, patients with parkinson disease experienced lower rates of noninfectious complications (odds ratio 0.32; 95% ci, 0.15¿0.63; p = 0.002) and fewer unplanned reoperations (odds ratio 0.60; 95% ci, 0.39¿0.92; p = 0.02).Conclusion: analysis of a national database suggests that dbs is a relatively safe treatment across several different patient populations.These overall favorable results support the continued practice of dbs surgery and provide encouraging validation for increasing access to dbs therapy for new indications that are being actively investigated.Reported events:  less than eight patients with dbs implanted for other diagnosis experienced postoperative infection, which included sepsis, deep surgical site infection, superficial surgical site infection, and organ space surgical site infection.Five patients with dbs implanted for other diagnosis experienced noninfectious complications, which included stroke and wound disruption.Less than 11 patients with dbs implanted for other diagnosis experienced unplanned reoperation.Less than 8 patients with dbs implanted for other diagnosis experienced readmission within 30 days.Information regarding patient complications, readmission subcategories, and reoperations beyond 30 days after the procedure was not available.

Manufacturer Narrative

Kimata, a.R., koester, s.W., ma, k.L., catapano, j.S., zavala, b., whiting, a.C., ponce, f.A.Characterizing the trends in patient demographics, complications, and short-term outcomes after deep brain stimulation procedures.Interdisciplinary neurosurgery, 28, 101466.(2022).Doi: 10.1016/j.Inat.2021.101466.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.The date of death(s) was not provided in the article.Please note that this date is based off of the date that the article was accepted for publication as the event dates and publication date were not provided in the published literature.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.Other relevant device(s) are: product id: neu_ins_stimulator, 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.

• 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: 13794928
• MDR Text Key: 291327295
• Report Number: 2182207-2022-00447
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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
• Date Manufacturer Received: 02/16/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male