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

Model Number 97715

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

Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 03/26/2021

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 who was implanted with an implantable neurostimulator (ins) on (b)(6) 2021.It was reported that patient recently had a scs implanted on (b)(6) 2021 with hopes as a last resort for some form of pain relief and has been extremely disappointed in the product has had zero benefit. no device malfunction was reported.Additional information received from patient on (b)(6) 2021.Patient responded back from follow up sent and reported significant increase of lumbar pain now daily #8-9 constant, after scs implanted now for the first time have radiating pain to both legs and feet, decrease activity due to the increased pain level.There are no additional factors or explanation for the increase pain level only change was the scs was implanted.The steps that patient has taken and will continue to take are weekly meetings with a manufacturer representative to make scs adjustments and try different programming with the hopes they find something that will help.As to patient's knowledge the scs was last resource for pain relief, the scs as well as all previous surgeries, procedures seem to make issues worse after everyone.Issue has not been resolved.Patient's last meeting with rep was on (b)(6) 2021 and rep indicated they would try new programming and then they can discuss removal if lack of improvement.The patient noted on (b)(6) 2021 that the patient constantly has pain going down their legs and zero relief from the spinal cord stimulation.The patient noted that it affects everything including the patient's sleep, movement, activities, and a constant need to lay flat.The patient has had multiple meetings with a manufacturer representative to make weekly spinal cord stimulation adjustments and the surgeon is now scheduling a revision surgery of the spinal cord stimulation to try and resolve the issues.The lack of relief has not been resolved.The patient has had increased pain meds as a result.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12053258
• MDR Text Key: 266074957
• Report Number: 3004209178-2021-09862
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Date Device Manufactured: 11/17/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 100