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	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lead was inserted and testing cable was connected.While running the verification test, the resident connected the monopolar cable to the lead test cable just as the verification process was being completed so it came back as unable to verify.The manufacturer's representative (rep) reset the configuration to include the monopolar test cable and ran the test again and it continued to be unverified.The rep ran an impedance test and almost all contacts were showing red.Contact 1 was the only one that had some yellow.It was reported the issue could possibly be related to the dbs app, since it started working after restarting the app.The cable was disconnected and reconnected and tried some half turns but the error remained.After trying this a couple of times, they tried a new testing cable but got the same result.So, a new lead was then opened and again got the same result.The rep rechecked the lead configuration set up and it was all correct.At this point, the dbs app was closed down and restarted a new ens connection.When the rep reran the verification, it came back ok and impedances were normal.The issue was resolved at this time.
Additional Manufacturer Narrative
Section d10 references: product id a610 lot# serial# unknown.Product type software product id neu_stylet_acc lot# serial# unknown.Product type accessory product id b3300542 lot# serial# (b)(6).Product type lead product id b31040 lot# 082n23621.Product type screening device product id b3300542 serial# (b)(6).Product type lead product id b31040 lot# 082n23621.Product type screening device section d information references the main component of the system.Other relevant device(s) are: product id: b3300542, serial/lot #: (b)(6), ubd: 04-nov-2023, udi#: (b)(4) h3.Analysis of the lead (s/n (b)(6)) found no anomaly.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20034250
• Report Number: 2182208-2024-03569
• Device Sequence Number: 6414306
• Product Code: MHY
• UDI-Device Identifier: 00613994972286
• UDI-Public: 00613994972286
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 66 KG