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

Model Number 37714

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(4), ubd: 14-nov-2016, udi#: (b)(4).Product id: 3778-60, serial/lot #: (b)(4), ubd: 14-nov-2016, 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 a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was patient (pt) called stating their battery was not on (patient service specialist (pss) understood ins battery) and they will have the leads changed next tuesday to something mri conditional or compatible.Pt desperately needed to have mri to be compatible for they have injury in other places and ct scans don't cut it.Pt said their ins battery was not working properly for the battery died sometime ago and they did not need it.Ps asked for clarifying information and wanted to know why the ps agent was asking questions since it was not their reason for call.Pt noted the ins battery died a long time ago and they no longer needed it a long time ago but they needed it now.Pt kept the ins charged but they did not use the device since probably 2014 or 2015 but they kept it charging until it would not charge several years ago.Pt then got their ins battery replaced and the leads was broken for it was not working properly and they noticed the leads were damaged recently when they put a new ins in.Pt had purchased and interferential device, the pts pain management said they should find compatibility.The pts ins was for their lower extremity and they had issues with upper extremity and their cervical spine.They wanted to use the interferential device for the upper extremity.

• 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: 15245844
• MDR Text Key: 298113911
• Report Number: 3004209178-2022-10484
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2022
• Date Device Manufactured: 10/30/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female