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); Migration or Expulsion of Device (1395); Unintended Collision (1429); Battery Problem (2885); Charging Problem (2892); Patient Device Interaction Problem (4001)

Patient Problems Inadequate Pain Relief (2388); Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger.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).It was reported that¿this morning when the patient went to charge their ins the charging duration was longer than normal.The patient stated it took them 5 hours to charge from 0% to a full charge.They stated that it took them 2 hours of charging before they could even turn on their stimulation.Pt stated that they have to charge their implant at least twice a day since the ins battery completely depletes due to high stimulation settings.They stated that their implant doesn't even hold a charge for 2 hours.During the call they attempted to charge their ins and was able to charge at excellent quality.They verified that their recharging mode was set at mode 4.They stated that their recharger (rtm) cord looked frayed near the paddle, it was noticed a couple weeks ago.The issue was not resolved through troubleshooting.An email was sent to replace the rtm.¿the patient stated that they do not sleep well and they cannot get their ins to last a charge over night for their ins was always depleted when they wake up.¿they mentioned that they only have one program and that the program is not 100% but its decent enough and works fairly well so they don't want to change the programming.They were also redirected to their representative in the event of wanting to look at ins programing options.They called again to report she has had issues with charging her ins battery and the rtm cord has been replaced numerous times.They stated she just had it replaced.Pt stated when she first got the rtm cord it worked fine.The patient stated she has been charging her ins since 5 am today (b)(6) 2021 she started charge with her ins battery at 0% and currently her battery is only at 60% with excellent charge quality.They stated she was charging twice a day - and it usually died in the middle of the night.The patient stated she has her stimulation amplitude set at 13.1.They stated she can barely feel stimulation unless she leans back for the past 6 months.They stated she really likes this program because it is hitting the right spots but she cannot keep going at this pace.They talked to their hcp this past week and has an appt this coming week to check her programming.Troubleshooting was unable to be performed.The patient was redirected to their healthcare provider to further address the issue.

Event Description

Additional information was received.It was reported that the patient was unsure of any circumstances and that no significant changes were made to cause the implantable neurostimulator (ins) to not hold a charge.The patient met with their manufacturer representative (rep) and healthcare provider for reprogramming to resolve the issue.The patient said that the ins is still not holding a charge for too long but it does hold the charge for about 10 hours each.The patient also said that they did meet with the rep for reprogramming but that the only program they like causes them to recharge twice a day.The patient also mentioned that in the last couple of days, they think their ins won't charge while sitting down (pt said thinking back, they started noticing this after they fell).Since the patient had reported the fall and gets excellent connection while walking around, patient services redirected the patient back to their rep.

Manufacturer Narrative

Continuation of d10: product id 97755 lot# (b)(6) implanted: explanted: product type recharger 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.

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.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

Additional information was received from the patient.It was reported that it was still taking hours to charge implant up and they were still charging implant 3 times per day.Patient said she knew her settings were high and could cause her to charge 2 x's a day but since implant was taking so long to charge up she was charging 3 x's a day.They were losing therapy because she wasn't able to get implant charged up enough in a normal amount of time to keep therapy on.A manufacturer representative (rep) gave them the option of different programs so that implant wouldn't deplete as quickly, but they didn't like those options and was going to stick with the program that was at 14 v that depleted the battery quicker because that one worked for her.The equipment didn't look right because: controller itself was warn, controller edges don't fit tightly together, screw loose on controller, connection between rtm and controller a bit loose, rtm paddle worn out, wires going into paddle look a teeny bit frayed from paddle bending at cable /paddle junction.

• 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: 11429589
• MDR Text Key: 238369220
• Report Number: 3004209178-2021-03814
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• 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: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 56