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

Model Number 97715

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Application Program Problem (2880); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 977a260 lot# serial# (b)(4), implanted: (b)(6) 2021, product type lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 03-feb-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins).It was reported that rep met the patient for her post op and she said she was getting a message on her controller that said settings unavailable.Upon interrogation an impedance check revealed electrode 0 should be avoided.Each of her groups were utilizing this electrode hence why she was unable to turn any of her groups stronger.Rep reprogrammed around the electrode and it solved our problem.She was able to turn her system up as strong as she needed.The issue has been resolved.Connectivity check was normal.The issue was resolved.No symptoms were reported.Additional information was received from a manufacturer representative (rep).It was reported that impedance settings were at 40,000 ohms on electrode 0.The rep programmed around it and the patient is doing great.The rep had nothing further to report.The rep stated that the physician is aware.The patient has a peripheral nerve stimulation system and reports that the left lead is not helping with her pain relief.She reports that two weeks after surgery, she was kicked in the rear end, and ever since then, she has not noticed much relief on her left side.The office ordered an x-ray and reviewed initial and current lead placement and the films indicate that there was a slight migration in the left lead.The manufacturer representative tried reprogramming the patient on (b)(6) 2021 to see if they could broaden the left-sided coverage; however, they were unsuccessful at reprogramming.The patient does not feel much stimulation on the left where she needs it after the reprogramming session.The patient is still going to test out the higher pulse width, and if she is not any better, she will call the health care professional office to have them schedule a revision surgery of the left lead.

• 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: 12478723
• MDR Text Key: 271686696
• Report Number: 3004209178-2021-13917
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Date Device Manufactured: 02/26/2021
• 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 Age: 34 YR