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

Model Number 97715

Device Problems Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burning Sensation (2146); Electric Shock (2554)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 977a260, serial/lot #: va2d7xe005, ubd: 18-mar-2025, udi#: (b)(4) ; product id: 977a260, serial/lot #: va2cwyv015, ubd: 03-mar-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).It was reported that the patient states that she was experiencing shocking, burning sensations at the lead incision and ins incision sites when the stimulation is on.Says she does not experience this when stimulation is off.The manufacturer representative (rep) will meet with the patient on 07/01 to evaluate the system.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: 2021-(b)(6) explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: 2021-(b)(6) explanted: 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

Additional information was received from a rep.The rep met with the patient on (b)(6) 21 and interrogated the ins, all impedances were within normal limits.The patient stated that she feels stimulation everywhere she needs it and denies any rib or abdominal stimulation.The rep reprogrammed her to a program in which she doesn¿t feel the stimulation, however, she said she still feels ¿shocking and burning from the ins along the lead to her spine¿ when the stimulator is on.The patient would like the device explanted and has an appointment on (b)(6) 21 with the physician to discuss explant.

• 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: 12093503
• MDR Text Key: 264502531
• Report Number: 3004209178-2021-10183
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR