MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Pain (1994); Scar Tissue (2060); Complaint, Ill-Defined (2331); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 02-mar-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient and manufacturing representative (rep) regarding the patient's implantable neurostimulator (ins).Information was reported that the patient has sharp pain at their battery site.It feels like something is poking her from behind.The patient's ins battery is in their back.There are no factors that may have contributed to this.The physician's assistant palpated around the device and said that it could possibly be scar tissue forming around the leads that are coiled behind the battery.No surgery is planned at this time.The patient was referred back to her primary pain physician for a possible steroid shot to see if they can reduce the scar tissue.The patient's case will be discussed with the implanting physician to see what he recommends.

Event Description

Additional information was received from the manufacturer's representative.It was reported that the cause was not determined at thi s time.Rep clarified that the excess lead was coiled up behind the ins in the pocket.The coiled lead was done intentionally during surgery to fit into the pocket.The concern was that patient could possibly have thicker scar tissue forming around that part of the lead which would cause her pain.However it was undetermined if this was the cause or not.Patient was referred back to hcp for possible steroid injections.The surgeon may still recommend a revision at pocket site.Issue not resolved at this time.

Manufacturer Narrative

Continuation of d11: product id 977c165 lot# serial# (b)(6), implanted: (b)(6) explanted: product type lead.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 healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was hcp called to see if mdt rep was coming to the surgery case.Mdt rep walked in while caller was on the phone with technical services (ts).Caller said the dr.(b)(6) is going to move the ins to a new location because the patient (pt) is "having difficulty." ts asked but caller did not know what the difficulty was.Caller ended the call before ts could gather any more information.

Manufacturer Narrative

Continuation of d10: product id: 977c165, serial# (b)(6), implanted: (b)(6) 2017, product type: lead.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: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10349888
• MDR Text Key: 201200374
• Report Number: 3004209178-2020-13210
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention