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

Model Number 37714

Device Problems Break (1069); Disconnection (1171); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Collision (1429); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 3777-45 lot# serial# (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2023, product type lead product id 3777-45 lot# serial# (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2023, product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3777-45, serial/lot #: (b)(6), ubd: 28-nov-2015, udi#: (b)(4) ; product id: 3777-45, serial/lot #: (b)(6) , ubd: 16-dec-2015, udi#: (b)(4).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 Description

Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).The patient reported they had multiple falls in 2017 and the device has been non-functioning for the last 6 years.The falls were followed by additional spine surgery, after which the pain resolved and patient no longer needed use of the stimulator.Patient reported pain returned in (b)(6) 2023.At this point the ins battery was dead (implanted in 2012) and patient was told their leads were broken.A loss of stimulation was reported.Imaging performed showed a lead had pulled out of the battery, which is why it wasn't working.The leads themselves are intact.Rep discussed with hcp about testing existing leads in new battery, but hcp declined as the leads had been pulled back a full vertebral level and were not mri compatible.The cause was the falls from 2017.The issue was resolved with full system replacement.The devices were discarded.Rep will report additional information that becomes available.On 2023-nov-14 additional information was received from the rep.The rep reported the battery was replaced as it had reached eos and considered normal replacement.The serial number of which lead that was pulled out of the battery could not be provided.

• 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: 18249022
• MDR Text Key: 329507538
• Report Number: 3004209178-2023-25001
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2023
• Date Device Manufactured: 07/31/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male