MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.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 reported via the manufacturer representative that they were not getting stimulation since an unrelated surgery.The patient noted that the implant was depleting faster and they don't need it or use it.Impedances were checked and all were out of range.The patient was not getting any stimulation when at full power and all electrodes.It was noted the patient had lost 75lbs since being implanted.The issue was resolved at the time of the report.The patient later reported that something must of been done during the unrelated surgery that caused the issues with the stimulator.The patient was going to have a lead revision so she still had the option of using the stimulator for relief.
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Event Description
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Pt had an appointment with hcp today.Upon impedance check now lead 0-7 is completely out as well.The hcp got an x-ray in office and lead tips were mid t7.Pocket revision/lead revision with be scheduled.
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Manufacturer Narrative
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Continuation of d10: product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; 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.
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Manufacturer Narrative
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Continuation of d10: product id: 977a260, serial# (b)(6), implanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial# b)(6), implanted: b)(6) 2016, product type: lead.Product id: 977a260, serial# b)(6), implanted: b)(6) 2016, product type: lead.Product id: 977a260, serial# b)(6), implanted: b)(6) 2016, 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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Rep reported whole leads impedance out or range cause is undetermined.Hcp believes the leads pulled from the ipg, but that is not confirmed.Revision date is yet to be scheduled.
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Event Description
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Additional information was received from the manufacturer representative (rep).It was reported that the patient had the ins replaced today along with one lead.The patient right lead during the impedance check had the top electrode as out of range and red.The healthcare provider was fine with one electrode being out.
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Manufacturer Narrative
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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: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; 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.
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Event Description
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Additional information received from the manufacturer representative reported that the patient had effective therapy.The patient came in for her post op and needed reprogramming due to an inability to increase intensity.Impedances showed electrodes 0 and 1 were greater than 40000 ohms.After programming around those electrodes the patient had no issues.
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Manufacturer Narrative
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Continuation of d10: product id: 97791; product type: accessory; product id: 977a260; lot# serial#: (b)(6); implanted: on (b)(6) 2016; explanted: on (b)(6) 2021; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; product id: 977a260; lot#serial#: (b)(6); implanted: on (b)(6) 2016-; explanted: on (b)(6) 2021; product type: lead; product id: 977a260; lot# serial#: (b)(6); implanted: on (b)(6) 2016; product type: lead; h3.Analysis of the implantable neurostimulator found no anomaly.Analysis of the lead with serial number: (b)(6) found that all conductors were broken 23.1 centimeters from the distal end of the 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.
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