MAUDE Adverse Event Report: MEDTRONIC, INC. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97725
Medical Device Problem Codes	Human-Device Interface Problem (2949); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id 977a260; serial#: (b)(4); product type: lead.Product id: 97725; serial#: (b)(4); product type: external neurostimulator.Product id 977a260; serial#: (b)(4); product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 15-sep-2024, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 08-jun-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a trial, two different trial leads were used with two different wireless external neurostimulators and they could not get the connectivity check to show all green.At most, they got 4 green connections.They pulled the initial lead and put in the new one and it was displaying the same 4 contacts as compromised; however, the manufacturer representative wasn't doing a quad lead configuration.They tried both leads with both wireless external neurostimulators and both ports on the wireless external neurostimulators.They ran an electrode impedance check and they were seeing "do not use" for most of the contacts.
Event or Problem Description
The rep reported on january 5, 2020 that a total of 3 leads and 2 wens were associated with this trial.The first wens and 1st lead used that had connectivity issues intra-op were the devices that were returned for analysis.During the trial, the patient had used the 2nd wens that was not returned along with 2 leads.When the patient went to post-op, the connectivity and impedances were checked again and were found to be resolved.The patient continued on with the trial, which went well.The wens and two leads that were used during the trial were not returned to the rep, so they weren't sent back for analysis.The rep stated either they were discarded or were still in the possession of the hospital.
Additional Manufacturer Narrative
Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: explanted: product type lead product id 977a260 lot# serial# unknown implanted: explanted: product type lead product id 97725 lot# serial# nlj363765n implanted: explanted: product type external neurostimulator product id 977a260 lot# serial# va27klp036 implanted: 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.
Additional Manufacturer Narrative
H3: analysis of the 97725 serial# (b)(6) found no anomaly.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.
Additional Manufacturer Narrative
Product type lead product id 977a260 lot# serial# unknown implanted: explanted: h3.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.H6.Evaluation result code 3233 does not apply.Evaluation method code 4118 does not apply.Evaluation conclusion code 11 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
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10977184
• Report Number: 2182207-2020-01433
• Device Sequence Number: 17208085
• Product Code: LGW
• UDI-Device Identifier: 00763000258115
• UDI-Public: 00763000258115
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/05/2021; 02/17/2021; 03/04/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/05/2021; 02/19/2021; 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 100