MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97725

Device Problem Connection Problem (2900)

Patient Problems Cerebrospinal Fluid Leakage (1772); Paralysis (1997); Spinal Cord Injury (2432)

Event Date 04/04/2022

Event Type  Injury  

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with a lead for neuro stimulation.It was reported that a patient had an issue occur while implanting the surgical paddle.Due to heavy scar tissue, the patient had a dura tear.The physician put a plug (should have confirmed the caller meant patch).The caller reported the physician did implant the lead which is currently not connecting to anything.Now the patient is post op and is experiencing paralysis.On (b)(6) 2022 (rep): additional information was reported that the lead was implanted on (b)(6) 2022.They planned on a trial but took the patient back to operating room and attached vanta system so they could get an mri.Put in a drain and no blood patch.The cause of the dura tear was scar tissue from a previous surgery during laminectomy decompression.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, implanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2022 product type lead product id 977006 serial# (b)(6) product type implantable neurostimulator 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

Rep reported that steps taken towards resolution were unknown.Pt has been moved from hospital to rehab facility.All we know at this time.Weight was unknown.Rep provided device information.The provided information has been confirmed with the physician/account.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14197239
• MDR Text Key: 290545704
• Report Number: 2182207-2022-00689
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000278762
• UDI-Public: 00763000278762
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/10/2022
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention