MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 37714

Device Problems High impedance (1291); Connection Problem (2900); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2022

Event Type  malfunction  

Event Description

Mdt rep called while inter-op for normal ins replacement.Rep reports that when the dr tried to remove the 8-15 lead tail from the old ins it was not easy to remove.When they did get it removed the electrode end of the lead tail was discolored and there seemed to be something on the lead.The dr was able to remove some of the foreign material on the lead tail and then insert it into the new intellis.Rep reports it was hard to insert the lead into the intellis.Rep reports after the lead was inserted some of the contact pairs on the 8-15 lead tail were >40k ohms.Rep will try to reprogram while avoiding the out-of-range electrodes on the 8-15 lead tail.Additional information received from the manufacturer representative reported that the material was believed to be a silicone material between the electrode contacts.The impedance issue had been corrected and the patient was receiving effective therapy.It was on the electrode contacts that insert into ins.High impedances were resolved; therapy was returned to expected levels.

Manufacturer Narrative

Continuation of d10: product id 39565-65 serial# (b)(6) implanted: on (b)(6) 2014 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(6), ubd: 24-oct-2017, udi#: (b)(4).This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18231689
• MDR Text Key: 329285470
• Report Number: 3004209178-2023-24398
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2022
• Date Device Manufactured: 08/14/2013
• 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
• Treatment: "SEE H10...."
• Patient Age: 63 YR
• Patient Sex: Male