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

Model Number 97715

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) via a patient with an implantable neurostimulator (ins) for non-malignant pain.Beginning a few days ago the stimulation was turning on and off- not the ins is turning on and off.The rep met with the patient on 2018-feb-08 and enabled adaptive stimulation (as) due to believing the patient had positional stimulation.Tonight the patient called the rep and stated that they are still experiencing intermittent stimulation sensation.The rep would meet with the patient maybe tomorrow morning to troubleshoot further.The rep did not check the dairy to see if the ins was actually turning on or off but they did report that the ins has always been charged.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacture representative (rep) on 2018-feb-09.The rep stated that the cause still remains unknown.The patient is travelling and they are scheduled to meet next tuesday.The rep directed the patient to turn off adaptive stimulation (as).The rep would call technical support to pull the file report.Additional information was received from the rep on 2018-feb-13.The rep re-iterated that the patient feels the stimulation sensation go away when sitting and laying back.With as enabled the issue continued but occurred more randomly.The ins will show the stimulation is on even though the patient does not feel it.All impedances were in range/green around 800-1000 ohms.The rep re-checked the impedances with the patient standing and feeling stimulation and impedances were similar.They obtained an x-ray last week and it appears the lead may have shifted.The patient was walking their dog and their dog pulled and this is the only activity they can correlate with the change in stimulation.It was confirmed that the cycling is off, amplitudes were set for all positions except reclining and laying front, and the patient feels the stimulation in their lower back and legs as intended when they are feeling it.It was noted that they do not feel it in any inappropriate areas.The rep tried turning the amplitude up when the patient was not feeling the stimulation but the patient still could not feel it even with the increased amplitude.Technical services discussed palpating the system but the patient is still tender and sore at the implant site.The rep tried using a different part of the lead but the patient had the same issue; felt stimulation while standing but not while sitting.No further complications were reported/are anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 977a260, lot# serial#: (b)(4), implanted: (b)(6) 2018, product type lead product id: 977a260, lot# serial# (b)(4) implanted: (b)(6) 2018 explanted: product type lead additional fdd code (b)(4) applies to the leads (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep reported that the lack of stimulation while sitting was resolved through reprogramming, and that the patient was feeling stimulation in all positions now.The rep confirmed that the lead moved slightly, but that it should be insignificant.Overall the issue was resolved.No further complications were reported.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7259831
• MDR Text Key: 99939068
• Report Number: 3004209178-2018-02990
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2018

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: 12/28/2018
• 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: 02/07/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 02/09/2018; 04/11/2018
• Supplement Dates FDA Received: 02/28/2018; 04/24/2018
• Date Device Manufactured: 01/05/2018
• 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: 36 YR
• Patient Weight: 68