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

MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Cellulitis (1768); Hemorrhage, Subdural (1894); Unspecified Infection (1930); Thrombosis (2100)

Event Date 03/06/2020

Event Type Injury

Manufacturer Narrative

Age.This value is the average age of the patients reported in the article as specific patients could not be identified.Sex.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event.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.Yarema b.Bezchlibnyk, vibhash d.Sharma, kushal b.Naik, faical isbaine, john t.Gale, jennifer cheng, shirley d.Triche, svjetlana miocinovic, cathrin m.Buetefisch, jon t.Willie, nicholas m.Boulis, stewart a.Factor, thomas wichmann, mahlon r.Delong, robert e.Gross.Information references the main component of the system and other applicable components are: product id: neu_unknown, serial#: unknown, product type: unknown.Product id: neu_unknown, serial#: unknown, product type: unknown.Product id: 3389, lot#: unknown, product type: lead.Product id: neu_unknown, serial#: unknown, product type: unknown.Product id: 3389, lot#: unknown, product type: lead.Product id: neu_unknown, serial#: unknown, product type: unknown.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: 3389, lot#: unknown, product type: lead.Product id: neu_unknown, serial/lot #: unknown.Product id: neu_unknown, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: neu_unknown, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: neu_unknown, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Yarema b.Bezchlibnyk, vibhash d.Sharma, kushal b.Naik, faical isbaine, john t.Gale, jennifer cheng, shirley d.Triche, svjetlana miocinovic, cathrin m.Buetefisch, jon t.Willie, nicholas m.Boulis, stewart a.Factor, thomas wichmann, mahlon r.Delong, robert e.Gross j neurosurg doi: 10.3171/2019.12.Jns192010.Objective deep brain stimulation (dbs) lead placement is increasingly performed with the patient under general anesthesia by surgeons using intraoperative mri (imri) guidance without microelectrode recording (mer) or microstimulation.The authors assessed the accuracy of lead placement, safety, and motor outcomes in patients with parkinson disease (pd) undergoing dbs lead placement into the globus pallidus internus (gpi) using imri or mer guidance.Methods the authors identified all patients with pd who underwent either mer- or imri-guided gpi-dbs lead placement at emory university between july 2007 and august 2016.Lead placement accuracy and adverse events were determined for all patients.Clinical outcomes were assessed using the unified parkinsonâ¿¿s disease rating scale (updrs) part iii motor scores for patients completing 12 months of follow-up.The authors also assessed the levodopa-equivalent daily dose (ledd) and stimulation parameters.Results seventy-seven patients were identified (mer, n = 28; imri, n = 49), in whom 131 leads were placed.The stereotactic accuracy of the surgical procedure with respect to the planned lead location was 1.94 â± 0.21 mm (mean â± sem) (95% ci 1.54â¿¿2.34) with frame-based mer and 0.84 â± 0.007 mm (95% ci 0.69â¿¿0.98) with imri.The rate of serious complications was similar, at 6.9% for mer-guided dbs lead placement and 9.4% for imri-guided dbs lead placement (rr 0.71 [95% ci 0.13%â¿¿3.9%]; p = 0.695).Fifty-seven patients were included in clinical outcome analyses (mer, n = 16; imri, n = 41).Both groups had similar characteristics at baseline, although patients undergoing mer-guided dbs had a lower response on their baseline levodopa challenge (44.8% â± 5.4% [95% ci 33.2%â¿¿56.4%] vs 61.6% â± 2.1% [95% ci 57.4%â¿¿65.8%]; t = 3.558, p = 0.001).Greater improvement was seen following imri-guided lead placement (43.2% â± 3.5% [95% ci 36.2%â¿¿50.3%]) versus mer-guided lead placement (25.5% â± 6.7% [95% ci 11.1%â¿¿39.8%]; f = 5.835, p = 0.019).When updrs iii motor scores were assessed only in the contralateral hemibody (per-lead analyses), the improvements remained significantly different (37.1% â± 7.2% [95% ci 22.2%â¿¿51.9%] and 50.0% â± 3.5% [95% ci 43.1%â¿¿56.9%] for mer- and imri-guided dbs lead placement, respectively).Both groups exhibited similar reductions in ledds (21.2% and 20.9%, respectively; f = 0.221, p = 0.640).The locations of all active contacts and the 2d radial distance from these to consensus coordinates for gpi-dbs lead placement (x, â±20; y, +2; and z, -4) did not differ statistically by type of surgery.Conclusions imri-guided gpi-dbs lead placement in pd patients was associated with significant improvement in clinical outcomes, comparable to those observed following mer-guided dbs lead placement.Furthermore, imri-guided dbs implantation produced a similar safety profile to that of the mer-guided procedure.As such, imri guidance is an alternative to mer guidance for patients undergoing gpi-dbs implantation for pd.Pli 10: it was reported that 1 patient aged (b)(6) had an infection and required explantation of unilateral dbs lead, extension, and ipg.Pli 20: it was reported that 1 patient aged (b)(6) had an infection and required explantation of unilateral dbs lead, extension, and ipg.Pli 30: it was reported 1 patient aged (b)(6) had deep vein thrombosis/pulmonary embolism.Pli 40: it was reported that a patient aged (b)(6) had the patient had multiple erosions requiring revisions of bilateral leads, leading to lead explantation and pallidotomy.Pli 50: it was reported 1 patient aged (b)(6) had their ipg and extension wire infected required explantation pli 60: it was reported that 1 patient aged (b)(6) had erosion over their lead requiring i & d and z-plasty pli 70: it was reported 1 patient aged (b)(6) had their ipg and extension wire infected required explantation.Pli 80: it was reported that 1 patient aged (b)(6) had a small right subdural hematoma.Pli 90: it was reported that 1 patient aged (b)(6) had a small right subdural hematoma.Pli 100: it was reported that 1 patient aged (b)(6) had a left subdural hematoma.Pli 110: it was reported that a patient aged (b)(6) had cranial cellulitis that was treated with iv antibiotics.Pli 120: it was reported that a patient aged (b)(6) had a revision of their unilateral lead with imri-dbs.Pli 130: it was reported that a patient aged (b)(6) had a revision of their unilateral lead with imri-dbs.Pli 140: it was reported that a patient aged (b)(6) had a revision of their unilateral lead with imri-dbs.Pli 150: it was reported that a patient aged (b)(6) had a bilateral lead revision with bilateral stn-dbs.Pli 160: it was reported that a patient aged (b)(6) had a unilateral lead revision with mer-dbs.The following device specifics were provided: lead model 3389.

Manufacturer Narrative

Event Description

Pli 80: it was reported that 1 patient aged 60 had a small right subdural hematoma that was seen postoperative imaging.It was treated with either a skull-mounted system or scalp-mounted platform.Pli 90: it was reported that 1 patient aged 73 had a small right subdural hematoma that was seen postoperative imaging.It was treated with either a skull-mounted system or scalp-mounted platform.Pli 100: it was reported that 1 patient aged 54 had a left subdural hematoma that was seen postoperative imaging.It was treated with either a skull-mounted system or scalp-mounted platform.

Manufacturer Narrative

Correction to display all related information 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.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 3389 lot# unknown serial# implanted: explanted: product type lead product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 3389 lot# unknown serial# implanted: explanted: product type lead product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead product id 3389 lot# unknown serial# implanted: explanted: product type lead 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.

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Brand Name

IMPLANTABLE NEUROSTIMULATOR

Type of Device

STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Manufacturer (Section D)

MEDTRONIC NEUROMODULATION

7000 central ave ne

minneapolis MN 55432

MDR Report Key

9936312

MDR Text Key

198074474

Report Number

6000030-2020-00161

Device Sequence Number

Product Code

MHY

Combination Product (y/n)

PMA/PMN Number

P960009

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

health professional,literatur

Type of Report

Initial,Followup,Followup,Followup

Report Date

04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

04/08/2020

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Model Number

NEU_INS_STIMULATOR

Device Catalogue Number

NEU_INS_STIMULATOR

Was Device Available for Evaluation?

Date Manufacturer Received

04/30/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

61 YR

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

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