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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431); Communication or Transmission Problem (2896); Loss of Data (2903); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 11/26/2019

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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was not able to adjust intensity with her controller.The patient could not confirm the message she saw on the controller when adjusting intensity, but she said it was similar to settings not available and that it can't respond to the request.The ins hadn't been charged in 3-4 weeks prior to seeing the message, but it was confirmed she could charge to 70% and the ins could communicate with the controller.The inability to adjust stim was noticed about 8 weeks prior to the report and the patient thought the "groups dropped out".The patient said the controller was "definitely malfunctioning" because "it used to be perfect".A loss of stimulation was also experienced about 6 weeks prior to the report.Before implant, the patient had really bad pain.Now, they had moderate pain and mobility problems.The original pain did not return, but they could tell they weren't getting any stim".An x-ray was taken and showed he leads were in the right places, but now the hcp thought something may have moved.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.Patient stated her stimulator had not worked in about 6 weeks and stated that the communication between her controller and ins were not doing well.Patient mentioned that last summer she started to have problems with the communication between her controller and ins, where it could get weaker and then "was just gone".Patient stated it would give messages where controller could not communicate with the ins.Patient mentioned ins worked wonderful for the first year and when she started to have this problem she met with reps for reprogramming where they would try to adjust things, however that was never fully successful.Patient confirmed she was talking about the problems she called in about in (b)(6) 2019.Patient stated she had only ever had this one problem, which had been ongoing since last summer.Additional information was received from the patient who reported that the x-ray did not show movement however suspicion continued.Patient stated the performance deteriorated gradually and then quit completely.Patient stated efforts at adjusting programming were not successful.A possible factor was a fall the patient had.Patient has an appointment on (b)(6).Patient reported over a month of discomfort.

Manufacturer Narrative

Continuation of d11: product id 977a260 lot# serial# (b)(6) implanted: 2018-(b)(6) explanted: 2020-(b)(6) product type lead 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Event Description

Information was received from a patient via manufacturer representative, regarding patient's implantable neurostimulator (ins).It was reported that impedances were over 40,000 on all contacts.Patient reported a loss of therapy after falling from her bicycle.Lead replacement was done and the issue was resolved.Hcp had no further information.No further complications were reported.2020-(b)(6) additional information was received from the rep.It was reported that patient had a bike fall.Impedance check revealed all over 40,000 except for 1 electrode.  patient moved out of the area and was going to have replaced when she moved.Rep further stated that this is one of those patients that is seen a lot by the reps.She looked up patient notes and stated that on (b)(6) 19, she saw the patient and found 0-7 electrodes were out of range (oor).Rep was able to program and provide relief to patient.On (b)(6) 2020, per notes entered by another rep, lead impedances were >40,000 ohms and the leads have migrated down one vertebral body.Revision was requested at that point but not scheduled due to covid-19.No further complications were reported.2020-(b)(6) additional information was received from the rep.It was reported that impedance check was done to determine high impedances.The lead revision/replacement was done on (b)(6) 2020.The explanted lead was going to be returned to the manufacturer.The issue was resolved.Patient's weight information and notified date was provided.No further complications were reported.

Manufacturer Narrative

Continuation of d11: product id: 977a260, serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.Product id: 97791, lot# unknown, product type accessory.Analysis of the lead found that all conductors were broken at the inject anchor site 22.3 cm from the distal end.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9672462
• MDR Text Key: 178017662
• Report Number: 3004209178-2020-02654
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 47