MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Insufficient Information (4580)

Event Date 01/10/2024

Event Type  Injury  

Event Description

Singh h., sawal n., gupta v.K., jha r., stamm m., arjun s., gupta v., rolston j.D.Increased electrode impedance as an indicator for early detection of deep brain stimulation (dbs) hardware infection: clinical experience and in vitro study clinical neuroscience 2024 doi: 10.1016/j.Jocn.2024.01.004 abstract: background: when deep brain stimulation (dbs) infections are identified, they are often too advanced to treat without complete hardware removal.New objective markers to promptly identify dbs infections are needed.We present a patient with gpi (globus pallidus interna) dbs for dystonia, where the electrode impedance unexpectedly increased 3-months post-operatively, followed by serologic and hematologic markers of inflammation at 6-months, prompting explantation surgery.We recreated these conditions in a laboratory environment to analyze the pattern of changing of electrical impedance across the contacts of a dbs lead following staphylococcus biofilm formation.Methods: a stainless-steel culture chamber containing 1 % brain heart infusion agar was used.A dbs electrode was dipped in peptone water containing a strain of s.Aureus and subsequently introduced into the chamber.The apparatus was incubated at 37 c for 6 days.Impedance was measured at 24hr intervals.A control experiment without s.Aureus inoculation was used to determine changes in impedance over a period of 6-days.Results: the mean monopolar impedance on day-1 was 751.8 ± 23.8 and on day-3 was 1004.8 ± 68.7 , a 33.7 % rise (p = 0.007).A faint biofilm formation could be seen around the dbs lead by day-2 and florid growth by day-3.After addition of the linezolid solution, a 15.9 % decrease in monopolar impedance was observed from day 3¿6 (p = 0.003).Conclusion: this study gives insight into impedance trends following a hardware infection in dbs.Increased impedance outside expected norms may be valuable for early prediction of infection.Furthermore, timely management using antibiotics might reduce the frequency of infection-related explant surgeries.  reported events: 1) a step-wise increasing trend of electrical impedance in the left electrode was noticed starting from 3 months post operation.Increasing impedance was noticed with decreasing therapeutic effects in setting of dbs hardware infection.Explantation was performed 6 months post operation.2) serological markers of inflammation were positive at 6 months post operation.3) after the patient was implanted, there were no reported surgical complications.The patient developed a good micro-lesioning effect.See attached literature article.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id neu_unknown_ext (serial: unknown); product type: 0191-extension; brand name activa; product id 3389 (serial: unknown); product type: 0200-lead; brand name activa; product id 3389 (serial: unknown); product type: 0200-lead; date g2: citation: authors: singh h., sawal n., gupta v.K., jha r., stamm m., arjun s., gupta v., rolston j.D.Increased electrode impedance as an indicator for early detection of deep brain stimulation (dbs) hardware infection: clinical experience and in vitro study.Clinical neuroscience 2024.Doi: 10.1016/j.Jocn.2024.01.004 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 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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 18647001
• MDR Text Key: 334616962
• Report Number: 2182207-2024-00431
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• 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 Age: 14 YR
• Patient Sex: Male