MAUDE Adverse Event Report: MEDTRONIC, INC. RESTORE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37022
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: b3300542, lot# va2j1unv32, product type: lead; product id: b3300542m, lot# va2jyt1v09, product type: lead; product id: b31040, lot# 082n23621, product type: screening device; product id: b31040, lot# 082n26521, product type: screening device; product id: b3300542, lot#: va2j1unv22, implanted: (b)(6) 2022, product type: lead; product id: b3300542m, lot#: va2el72v24, implanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: b3300542, serial/lot #: (b)(4), ubd: 07-dec-2023, udi#: (b)(4); product id: b3300542m, serial/lot #: (b)(4), ubd: 09-feb-2024, udi#: (b)(4); product id: b3300542, serial/lot #: (b)(4), ubd: 09-dec-2023, udi#: (b)(4); product id: b3300542m, serial/lot #: (b)(4), ubd: 09-jun-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the manufacturer's representative (rep) in the or implanting sensight leads and testing with the external neurostimulator (ens) with the hcp.The caller stated that they tested leads in saline outside of the body and all impedances are good but when placed in the brain, the caller was getting high impedances, specifically segmented contacts 1 and 2 out of range.Caller stated they tried other leads and other testing cable but it didn't resolve when the leads were placed in the brain.Caller said the readings seemed erratic.Caller was advised to wipe leads and try again--this time bipolar contacts associated with 2a were out of range 14-24k ohms 2a/0 2a/1 2a/2.Technical services (ts) had caller create program on 2a/0 simple bipole and therapy impedance showed reading of 2350ohms.Technical services specialist (tss) brought on another tss and they noted they have seen where segmented leads in normal impedance test show high but when isolated via therapy impedance, they reflect normal and they should be good to implant.
Event or Problem Description
Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the impedance issues didn¿t resolve during the stage 1 procedure, but they were good/resolved when connected to the extensions and generator during the stage 2 procedure on april 26th.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id b3300542, lot# va2j1unv32, product type lead product id b3300542m, lot# va2jyt1v09, product type lead product id b31040, lot# 082n23621, product type screening device product id b31040 lot# 082n26521, product type screening device product id b3300542, lot# va2j1unv22, implanted: (b)(6) 2022, product type lead product id b3300542m lot# va2el72v24, implanted: (b)(6) 2022, 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.
Additional Manufacturer Narrative
Continuation of d10: product id b3300542, lot# va2j1unv32, product type lead product id b3300542m, lot# va2jyt1v09, product type lead product id b31040, lot# 082n23621, product type screening device product id b31040 lot# 082n26521 ,product type screening device product id b3300542, lot# va2j1unv22, implanted: (b)(6) 2022, product type lead product id b3300542m, lot# va2el72v24, implanted: (b)(6) 2022, 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.
Additional Manufacturer Narrative
H3: analysis of the leads va2j1unv32 and va2jyt1v09 found no anomalies.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.
Event or Problem Description
Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the impedance issues didn¿t resolve during the stage 1 procedure, but they were good/resolved when connected to the extensions and generator during the stage 2 procedure on april 26th.
Additional Manufacturer Narrative
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: RESTORE
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14160055
• Report Number: 2182207-2022-00667
• Device Sequence Number: 5932198
• Product Code: MHY
• UDI-Device Identifier: 00643169513013
• UDI-Public: 00643169513013
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: 37022
• Device Catalogue Number: 37022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/02/2022; 05/02/2022; 05/18/2022; 07/28/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/04/2022; 05/06/2022; 05/20/2022; 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male