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

Model Number 97715

Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Difficult to Remove (1528); Application Program Problem (2880)

Patient Problems Scar Tissue (2060); Insufficient Information (4580)

Event Date 04/15/2023

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 3587a, serial/lot #: unknown, implanted: (b)(6) 2001, product type: lead, g2.Foreign: ca, h6.Please note, annex a codes a0401 and a072201 apply to the lead only, and annex a code a1102 applies only to the ins.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 manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient was not getting stimulation and was seeing the out of regulation (oor) message.It was noted that the rep was with the patient at the time of the call to the manufacturer's technical services on (b)(6) 2023.Electrode impedance testing was performed and all results were within normal limits ranging from 1620 ohms to 2940 ohms.The patient had a cervical lead with an extension that were both implanted in 2002.The patient had three previous inss and a pocket adapter was added when the third ins was implanted.The current ins was implanted in (b)(6) of 2020.In (b)(6) of 2023, the patient stopped feeling stimulation and started seeing the oor message.Prior to that, it was working fine and there was no fall or trauma.The patient was reprogrammed but did not feel stimulation and oor was seen.Additional reprogramming was attempted where the active electrodes were changed, and pulse width was decreased but no stimulation was felt and oor was seen with these settings as well.It was noted that the ins was 80% charged.Additional information was received from the rep.It was reported that the rep was notified of the event on (b)(6) 2023.They tried many combinations, and the patient could not feel any stimulation at that time.On (b)(6) 2023, the rep was with the neurosurgeon in the operating room and after disconnecting the lead from the extension, they found that the lead was damaged.When measuring impedance on a wireless external neurostimulator, results were all out of range.The lead was broken, and it was noted that it was 22 years old.This information was confirmed with the physician/account.

Event Description

Additional information was received from the rep.It was reported that the rep was notified of the problem on (b)(6) 2023 which was the day they saw the patient in the clinic.The lot number of the broken lead was not available.The lead was replaced with a new surgical lead.The broken lead was discarded because it was damaged and difficult to remove because of the scar tissue.The patient had good stimulation for pain with the new lead.

Manufacturer Narrative

H2.Correction: please note, based on the additional information received that the rep was notified of the problem on (b)(6) 2023, the date received by the manufacturer (g3) of 01-may-2023 that was noted on the previously submitted initial report was incorrect.The correct date the manufacturer received information that an adverse event or medical device malfunction had occurred was (b)(6) 2023.Also please note that h6 codes b17 and f19 no longer apply to this report based on additional information received.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
• 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: 17326110
• MDR Text Key: 319095546
• Report Number: 3004209178-2023-12663
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 07/27/2023
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention