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

Model Number 97715

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt states when woke up from surgery on the (b)(6) had pain.Pt walked in at a 4/5 and left with pain at a 10.Pt cannot even turn on the unit until this coming thursday.Pt wanted to know why this is.Pt was in the hospital for 3 days for this and taking dilaudid, norcos as well as taking double doses because pain was so unbearable.It hurts to sit, stand and walk.Pt cannot hardly walk and needs assistance, he was screaming for hours there because he hurt so bad.Pt states no matter how much drugs he's given, nothing helps.The pain is located in legs and feet to rear end.His incision part doesn't hurt all.Pt thinks the unit is touching a nerve or something and the hcp doesn't know what is going on yet.Pt has an appointment on (b)(6) and can't wait that long.It was also reported that patient is in excruciating pain and cannot walk without help after implant was put in, walked in with no problem with little pain now it's unbearable.A rep was going to meet with the patient on (b)(6) 2021.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the cause of the event was not determined and it was not confirmed that the device was hitting the nerve or that there were any device placement issues.The rep changed the patient¿s dtm program from ¿a¿ to ¿b¿ and reported that the patient has been doing better.The issue is reported as 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.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 NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11320637
• MDR Text Key: 231562996
• Report Number: 2182207-2021-00245
• Device Sequence Number: 1
• Product Code: LGW
• 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: 02/26/2021

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization