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)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a260 lot# serial# (b)(4) implanted: (b)(6) 2020 product type lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 27-nov-2023, udi#: (b)(4).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 patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient had high impedance, 40 ,000+ on nearly every contact.Patient had a loss of stimulation and return of pain rep attempted to reprogram the device to a different electrode but unable to do so.Hcp plans on doing a lead revision based on this information.That date has not been determined.

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

Additional information was received from a manufacturer representative (rep).The rep reported that patient was brought in for a lead revision by the healthcare provider (hcp).Connection check performed prior to procedure show all contacts out 0-7 and and 11, 13-14.Impedance check showed high impedances on all contacts.Physician opened the battery incision and unscrewed leads from battery.He wiped the contacts down and reinserted.Connections and impedance checks ran and appear the same as pre-op reading.Physician incised spinal pocket.He removed anchoring sutures.He removed one lead entirely.When he pulled out the remaining lead, he found that it was broken in half at distal end of anchor.It was visualized the other portion of the lead remaining in intrathecal space via fluoro.Physician made several attempts to retrieve this portion of the lead and was unable to get it.Another hcp, a spine surgeon was called in to assist with the case.He was able to retrieve the catheter after much time.Physician asked the surgeon if there would be any concern about placing new leads at this time.Surgeon denied any concerns.Physician placed new leads in the epidural space and reconnected to battery.Normal connection and impedance checks at this time.Programming resulted in adequate coverage of the patients painful areas.

Manufacturer Narrative

H3: analysis information -- 2023-07-25 13:51:24 cst pli# 20 product id# 977a260 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that all conductor(s) were broken; 42.0 cm from the proximal end of the lead.Analysis information -- 2023-07-25 13:46:24 cst pli# 30 product id# 977a260 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The lead was returned segmented; however electrical testing of the returned segment(s) determined that continuity was complete and there were no electrical shorts between the circuits.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: 16742413
• MDR Text Key: 313306600
• Report Number: 3004209178-2023-05012
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2023

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: 03/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 07/13/2023; 07/25/2023
• Supplement Dates FDA Received: 07/19/2023; 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Male