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); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Burning Sensation (2146)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: unknown, product type: recharger.Other relevant device(s) are: product id: 97755, serial/lot #: unknown, ubd: , udi#:.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 unknown indications for use.It was reported that their rtm cord is "heating up so bad that's burning into my skin, its on that box part and its on the cord part before the ring".Pt says this started happening "this week, it didn't burn the skin but it makes it red and it hurts a lot when the patient is charging and they don't want it to burn through my skin".

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that their recharger cord was "heating up so bad that it was burning into their skin, it was on the box part and it was on the cord part before the ring".They stated that this started happening "this week, it didn't burn the skin but it makes it red and it hurt a lot when the patient was charging and they don't want it to burn through their skin".Additional information was received and it was reported that the recharger box and cord were heating up where the cord met the paddle and burned through their skin a little bit.The recharger stopped working, wouldn't let them charge, and the controller showed that there was a problem with the recharger.They mentioned the screen said 3mn or something.

Manufacturer Narrative

Continuation of d10: product id: 97755; lot#serial#: (b)(6); 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.

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger.H3: product id 97755; serial# (b)(6); was returned for product analysis.Analysis found that the cable insulation was peeling away at donut end and wires are exposed.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.

• 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: 11886599
• MDR Text Key: 267055018
• Report Number: 3004209178-2021-08383
• 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,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR