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

Model Number	37714
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Electric Shock (2554)
Date of Event	03/17/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 37714, serial#: (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding a patient implanted with an implantable neurostimulator for non-malignant pain and failed back surgery syndrome.It was reported that the leads had broken and were out of place.The patient had the leads replaced.The patient reported that a few broken at first, and there was a shock and it stopped working.A lead revision was done, and the leads were replaced.
Additional Manufacturer Narrative
Continuation of d11: product id 3778-60 lot# serial# (b)(6), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type lead product id 3778-60 lot# serial# (b)(6), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type lead.Section d information references the main component of the system.Other relevant device(s) are: product is: 3778-60, serial/lot #:(b)(6), ubd:2016-07-03, udi#: section d information references the main component of the system.Other relevant device(s) are: product is:3778-60, serial/lot #:(b)(6), ubd: 2016-07-03, udi#: h6: additional review indicated patient code c50789 is no longer applicable to the event.Additional device and patient codes were added as they were omitted in original report.Patient had one implanted system, at the time of the event, so additional information regarding the event will be reported in this r eport.Refer to regulatory report # 6000153-2019-00007 for information that was previously reported regarding the lead (serial # (b)(6)).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
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8535440
• Report Number: 6000153-2019-00006
• Device Sequence Number: 14068053
• Product Code: LGW
• UDI-Device Identifier: 00643169157330
• UDI-Public: 00643169157330
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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 Expiration Date: 10/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR