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

Model Number 97715

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

Please refer to regulatory report #3004209178-2021-08674.The patient had two implanted systems and it was not clear which implanted system the issue occurred with.The referenced report pertains to the patient¿s other system.Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger.Product id: 97755, serial#: (b)(4), product type: recharger.Date of event: date inaccurate, only the month and year are valid.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 about a week ago the patient's recharger became hot and burned them.The patient applied ice to the area and the burn went away.The patient has two implantable neurostimulator and they used their rechargers interchangeably.They further noted that this week the patient's other recharger became hot and burned them.The patient applied ice to the area and the burn went away.Two replacement devices were requested.No further complications reported.

Event Description

Additional information was received.It was reported the issue was resolved.The patient's paddle still got hot and they still had trouble charging their neck.

Manufacturer Narrative

Concomitant medical products: product id 97755, lot#/serial# (b)(6), product type recharger product id 97755, lot#/serial# (b)(6), product type recharger product id 97715, lot#/serial# (b)(6), implanted: (b)(6) 2020, product type implantable neurostimulator 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.

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6) implanted: explanted: product type recharger product id 97755 lot# serial#(b)(6)implanted: explanted: product type recharger product id 97715 lot# serial# (b)(6) implanted: 2020(b)(6) explanted: product type implantable neurostimulator h3.Analysis found recharger (b)(6) had a recharge antenna failure, no device found message.Analysis found that for recharger (b)(6) the complaint was unverified.Rtm never got hot after running it for 10 mins.H6.Evaluation result code 3221 does not apply.Evaluation method code 4118 does not apply.Evaluation conclusion code 67 does not apply.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: 11921553
• MDR Text Key: 266880905
• Report Number: 3004209178-2021-08677
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 50 YR
• Patient Weight: 78