MAUDE Adverse Event Report: NEURO - VILLALBA INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems High impedance (1291); Migration or Expulsion of Device (1395)

Patient Problems Headache (1880); Pain (1994)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3778-45, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 3778-45, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.Other relevant device(s) are: product id: 3778-45, serial/lot #: (b)(4), ubd: 22-feb-2014, udi#: (b)(4).Product id: 3778-45, serial/lot #: (b)(4), ubd: 12-dec-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2021 (b)(4): information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for occipital neuralgia.It was reported that patient reported return of headaches and xray showed leads had migrated.High impedances on 2 electrodes.Issue not resolved at this time.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the rep reiterated that the patient's symptoms had returned and the stimulator was not helping with the pain anymore.The leads were replaced.The issue was resolved.

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.

Manufacturer Narrative

H3: analysis of serial# (b)(6), found: no anomalies.H3: analysis of serial# (b)(6), found: conductors #2 #6 were cut 7.1cm from distal end.Circuits #2 #6 were open.Circuits #0 #2 #6 were shorted.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): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 11991854
• MDR Text Key: 255969133
• Report Number: 6000153-2021-00028
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• 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 Age: 39 YR
• Patient Sex: Female