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

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Hearing Impairment (1881); Nausea (1970); Visual Disturbances (2140); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that a new system was implanted on (b)(6) 2020.The procedure was difficult due to epidural adhesions and scars.There was preoperative impression of small csf leak.Post-operative immediate onset of headache requiring 24 hours of bed rest.Since saturday, (b)(6), progressive orthostatic headache complaints.There was a constant headache when lying down with a pronounced increase when getting up (sitting, standing).Then also nausea and vomiting arose.These complaints were progressive.There was also photo and sonophobia.There was never a fever.There was no drowsiness.No other neurological symptoms.(b)(6): an epidural blood patch was placed to close the csf leak.On (b)(6) 2020, the patient was completely headache-free.The event was related to the implant procedure.The event was resolved without sequalae as of (b)(6) 2020.

Manufacturer Narrative

Continuation of d10: product type lead h6.Correction: added lead, and moved coding to the lead.G2.Foreign: belgium medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 11349888
• MDR Text Key: 232597694
• Report Number: 2182207-2021-00284
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 05/29/2024
• Date Device Manufactured: 04/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Weight: 75 KG