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

Model Number 97715

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: serial#: (b)(4), implanted: (b)(6) 2019, product type: lead; product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead; product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead; product id :977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 21-jun-2023, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4), ubd: 21-jun-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturing representative (rep) regarding a patient with an implantable neurostimu lator (ins).It was reported that the patient had an increase in post implant pain at the incision site of the leads and ins.The lead incision site area is visibly noticeably swollen.The pocket site is tender as well.The patient¿s chronic pain has gotten worse to where they feel the need to turn off the device.The patient did not want reprogramming until the incision site pain is under control.The patient was given a topical pain prescription to use on incision sites and has a follow up appointment with their healthcare provider on (b)(6) 2020.Reports that she felt a ¿pop¿ when pulling themselves up on a high mattress.They felt pain run down the right side of their body.Additional information was received from a manufacturer¿s representative (rep).The rep reported that pa thought the anchor suture may have failed as the cause of the lead incision site pain.The patient was to have surgery on (b)(6) 2020.Patient did pocket revision on 2020-06-03 so the pa thought ins site pain was likely post-operative swelling.The patient had not been using the device.It was unknown if there were any device issues identified to explain the ¿pop.¿.

Event Description

On august 8, 2020, the rep reported there was no additional information regarding the cause of the anchor sutures failing.The rep confirmed that the reported issues had been resolved.

Manufacturer Narrative

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.

• 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: 10279152
• MDR Text Key: 199039747
• Report Number: 3004209178-2020-12259
• 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
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR