MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
High impedance (1291); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 26-mar-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that after making the connection of the surgical lead to the ins, a system integrity check was performed.The parameter "connectivity checking" "comprobar conectividad" was measured, and contacts 4, 11, 12 presented bad connection.The patient didn´t experience signs or symptoms related to this issue.Troubleshooting was performed. after bad connection was observed, impedance where measured and contacts 7, 8,9, 13 and 14 presented high values of 40000, 40000, 22400, 12440 and 40000 ohms respectively. lead contacts where cleaned with sterile gauze and sterile water, then the each lead was connected to its socket.After that the parameter "connectivity checking" "comprobar conectividad" was measured and contacts 4, 10, 11, 12 and 13 presented bad connection.Later lead connection to the ins socket was inverted and results were bad connection in contacts 2, 3, 4, 5, 12.To resolve the issue a new surgical lead was opened and connected to the ins, a system integrity check was made and connections and impedance were good.The issue was resolved.There were no patient symptoms or complications associated with this event.No medical/surgical intervention or hospitalization was needed.There was no injury.
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Manufacturer Narrative
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G9- the manufacturing site id was previously reported as 2182207.Additional review indicates the correct manufacturing site id is 3 004209178.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.
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Manufacturer Narrative
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Continuation of d10: product id 977c165 lot# serial# (b)(6) implanted: (b)(6) 2022 explanted: (b)(6) 2022 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.
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Manufacturer Narrative
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Continuation of d10: product id 977c165, serial# (b)(6), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: lead.H3: product id 977c165, serial# (b)(6) was returned for product analysis.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.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.
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