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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date is estimated; month and year are valid.Continuation of d10: product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6), ubd: , udi#: 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 regarding an implantable neurostimulator for the treatment of spinal pain.The reason for call was patient stated they were having trouble getting the recharger to connect to anything.Patient stated the issue started a couple weeks ago and gradually has gotten to this point.Patient reported that this morning they were not able to charge; patient followed up saying that they tried to flip the recharger over and charge but that did not resolve the issue.Patient asked if it were possible for their interior battery to move.Patient stated that in the past their implant had been pushing on a nerve on their "good" leg and was causing them horrible pain.Patient noted that if someone were to touch their battery it would set them off; patient said that this pain has since gone away but that they think their battery has moved.Patientmentioned that they think their implant moved closer in; agent reviewed that the battery moving could be possible and that the patient could follow up with their doctor if the pain returns.Patient noted that when trying to charge this morning they were getting a message saying to charge the controller even when they knew the controller had battery in it.Patient mentioned that the recharger cord was hot.Agent had the patient inspect the recharger for any visible damage; patient confirmed no damage.Agent had the patient attempt to start a charging session; patient got no device found.Agent had the patient try again and then enter passive recharge.Patient stated that the number values were all 99's.Patient followed up saying the high switched to 100; shortly after the values dropped to all 0's.Agent reviewed information with the patient.The issue was not resolved.Agent sent an email to repair to replace the recharger.Agent advised the patient to try the replacement recharger and then if the pain returns or the issue is not resolvedto follow up with their doctor.

Manufacturer Narrative

H3: product id 97755, serial# (b)(6), was returned for product analysis.Analysis found that there was a failure with the recharger and that a "no device found" message was seen.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.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18791736
• MDR Text Key: 336366465
• Report Number: 3004209178-2024-05834
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1535-2021
• Patient Sequence Number: 1
• Treatment: "SEE H11...."; SEE H11
• Patient Age: 63 YR
• Patient Sex: Female