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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant of medical products: product id 97791, lot# /serial# unknown, product type accessory.Product id 97791, lot#/ serial# unknown, product type accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020, information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins).It was reported there were bumpy anchors that were secured to the fascia but the leads were moving freely through the anchor.There were no environmental, external, or patient factors that may have led or contributed to the issue.It was noted competitor anchors, bsx, was used and the bumpy anchors were left attached to the leads.The issue was resolved at the time of report.No symptoms were reported.No further complications were reported or anticipated.On 2020-june-04, additional information was received from the manufacturer representative (rep) reporting that the cause of the leads moving freely through the bumpy anchors was unknown.The rep stated that they were working to see if they could identify a cause.It was stated that the doctor did wait 15 to 20 seconds in the event the leads were wet and the leads still moved freely through the anchors.It was also mentioned that the hcp tugged on the leads pretty hard, so the rep was not sure if that contributed the issue.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.Supplementals for regulatory reports 2649622-2020-10624 and 2649622-2020-10625 will be captured in this system reported regulatory report going forward.

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep indicated that they have no additional information regarding the cause of the leads moving through the anchors.The rep provided the bumpy anchor serial numbers.No further complications were reported or anticipated.

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.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: 10131605
• MDR Text Key: 194663531
• Report Number: 3004209178-2020-09929
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR