MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Overheating of Device (1437); Pocket Stimulation (1463); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)

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

Event Date 06/28/2021

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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the reason for call was the controller wasn't recharging the implant (ins) and that it seemed like they were having to recharge the ins really frequently as the ins wasn't holding a charge.Pt stated that these issues started about five or six weeks ago.Pt was asked if any messages were appearing on the controller when they were trying to recharge the ins; pt stated that they had difficulty recharging the ins as the controller kept going back to saying to recharge the controller and then they would be charging it and it kept going back to the message that said that it needed to be recharged when they were actually charging it; pt clarified and stated that when they're recharging the ins, the device itself isn't working properly as when they try to recharge the ins, the controller keeps popping up messages saying that it needs to be recharged immediately.Patient was asked if the controller was saying that the controller needed to be recharged or if it was the ins that needed to be recharged and pt stated that sometimes it's the ins and other times it's the recharger.Pt confirmed the recharger (rtm) was getting hot while recharging the ins.Pt stated that the only way they could recharge the ins was by putting the rtm under them and laying on top of the rtm.Before they could walk around with the equipment to recharge the ins, however, now they couldn't even recharge the ins while sitting up.Pt stated that since the ins would only take a charge while lying flat on the rtm, they could feel a current going through at the site of where the ins was placed from the equipment which had never happened before.It was also reported that the recharging belt broke.A replacement rtm and belt was sent to the patient.

Manufacturer Narrative

Continuation of d10: product id: 97755, serial# (b)(6), product type: recharger.Product id: m943899a, serial# unknown, product type: accessory.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 received from the patient reported that "the device continue to give strong shock".

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6) product type recharger product id m943899a lot# serial# unknown product type accessory.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the reason for call was the controller wasn't recharging the implant (ins) and that it seemed like they were having to recharge the ins really frequently as the ins wasn't holding a charge.Pt stated that these issues started about five or six weeks ago.Pt was asked if any messages were appearing on the controller when they were trying to recharge the ins; pt stated that they had difficulty recharging the ins as the controller kept going back to saying to recharge the controller and then they would be charging it and it kept going back to the message that said that it needed to be recharged when they were actually charging it; pt clarified and stated that when they're recharging the ins, the device itself isn't working properly as when they try to recharge the ins, the controller keeps popping up messages saying that it needs to be recharged immediately.Patient was asked if the controller was saying that the controller needed to be recharged or if it was the ins that needed to be recharged and pt stated that sometimes it's the ins and other times it's the recharger.Pt confirmed the recharger (rtm) was getting hot while recharging the ins.Pt stated that the only way they could recharge the ins was by putting the rtm under them and laying on top of the rtm.Before they could walk around with the equipment to recharge the ins, however, now they couldn't even recharge the ins while sitting up.Pt stated that since the ins would only take a charge while lying flat on the rtm, they could feel a current going through at the site of where the ins was placed from the equipment which had never happened before.It was also reported that the recharging belt broke.A replacement rtm and belt was sent to the patient.Additional information received from the patient reported that "the device continue to give strong shock".

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12085198
• MDR Text Key: 258939062
• Report Number: 2182207-2021-01144
• 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,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Date Device Manufactured: 06/30/2020
• 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
• Treatment: "SEE H10...."; "SEE H11...."
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 53 KG