MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Disconnection (1171); High impedance (1291); Unintended Collision (1429); Energy Output Problem (1431); Application Program Problem (2880); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the reason for the call was the patient said they fell in february and think their leads were disconnected from the ins.The patient said they went to their healthcare provider (hcp) and had x-rays done today for the cervical and thoracic areas.The patient said when they went in for the x-rays, the technician said they wouldn't be able to see the leads from those viewpoints.The patient was looking for a different way to tell if the leads were disconnected or not but will be in a different state.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 lot# serial# (b)(6).Implanted: (b)(6) 2021; product type lead; product id 977a260; serial# (b)(6); implanted: (b)(6) 2021; 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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Event Description
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Additional information from the patient and manufacturing representative (rep) indicated that the patient fell and connectivity and impedance issues are not present in the lead.It was noted that a lead revision was scheduled.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2021 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2021 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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Event Description
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Information was received from a patient via manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that the patient had a fall and stim was not working normally.Pt also reported getting out of regulation message (oor) message.The rep saw the patient in the clinic and found out about connectivity issues; they turned stimulation off and scheduled the patient for replacement.After fall, x-ray looked normal and there was no lead migration. lead connectivity was bad for high impedances (40,000) on contacts 11-15.Therefore, the leads were replaced.This issue has been resolved.No symptoms reported.
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Manufacturer Narrative
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Continuation of d10: product id: 977a260, serial#: (b)(6), implanted: 2021 (b)(6), explanted: 2021 (b)(6), product type: lead.Serial#: (b)(6), implanted: 2021 (b)(6), product type: lead.A2: correction of the patient's date of birth.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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Event Description
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The patient's corrected date of birth was provided.
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Manufacturer Narrative
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H3: product id 977a260; serial# (b)(6); was returned for product analysis.Analysis found the conductors were broken 19cm from the distal end of the lead.D10: further review of the event determined that product id 977a260; serial# (b)(6); is not a complaint.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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