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

Model Number 97715

Device Problems Energy Output Problem (1431); Overheating of Device (1437); Battery Problem (2885)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 07/27/2021

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 and manufacturer representative (rep) regarding an implantable neurostimulator (ins) for spinal pain.It was reported that the patient's ins was heating up in the patient's back since a month or so ago.The patient mentioned they were scared when the ins first started heating up in the patient's back and the patient decided to allow the ins to deplete.The patient mentioned the ins was still heating up after the ins had depleted and the therapy was turned off.The patient met a manufacturer representative (rep) a week ago at the healthcare provider's office for appointment and the rep performed some troubleshooting, but could not resolve the issue.The patient contacted the rep again last night, and the rep told the patient to call to get the controller and the recharger antenna replaced.The patient was redirected to their healthcare provider to further address the issue. .

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

The patient controller and recharger were replaced to try and resolve the issue; however, the warmth and burning sensation did not resolve with external device replacement.Patient met with the manufacturer representative on (b)(6) 2021.Patient reported warmth, burning sensation, and heating sensation at the implantable neurostimulator site when stimulation was on, starting in (b)(6) 2021.The manufacturer representative tried various programming changes of rate, pulse width, electrodes, and this did not resolve the issue.Stimulation was also turned on and off to see how the patient would respond, and when the stimulation was turned on, the patient would report the heating at the implantable neurostimulator site about 15-20 seconds after stimulation was turned on, even if the manufacturer representative had not told them that the implantable neurostimulator had been turned on.Manufacturer representative did do pocket palpation also and this was negative for any pt response.Device only heats up on the inside, whereas palpation of the pocket area on the outside doesn't feel hot.No history of falls.Pt is feeling benefit from stim and like her stim therapy but has stop ped using it due to discomfort of heating at ins pocket.Pt has system for radicular pain in back and legs.Impedances were all normal range, and within 700 ohms.There is no evidence of pt twiddling the ins at the pocket and caller notes that it would be difficult because pt is very thin and the ins is tight in the pocket.The cause of these issues were not determined.A decision for replacement has not yet been made.

• 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
• MDR Report Key: 12384267
• MDR Text Key: 268684069
• Report Number: 3004209178-2021-13058
• 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
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR