MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 97800 |
Device Problems
Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 978b128, lot#: va2mx30, date implanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 03-mar-2024, udi#: (b)(4).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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that the patient had a lead and stimulator placed yesterday.The patient was not feeling stimulation, they tested with all standard programs and electrodes but the patient did not get stimulation sensation up to the maximum amplitude.During intraop testing the caller indicated that they got motor response on electrodes 1 2 3 at 1ma.The testing was completed prior to tunneling the lead.The caller stated that the lead was placed on the side contralateral to the ins, lead left side and ins on right side.The caller stated that there was tension and the doctor lost the lead as they were tunneling the lead.The caller indicated that think that there was too much tension on the lead but the doctor did not think that there was too much tension and elected not to anchor or suture the lead down in the pocket area.The doctor used a 28cm lead.The caller was not with the patient.Additional information was received from a manufacturer representative (rep).It was reported that the cause of the issue was undetermined.The rep stated that the most likely cause was the tension on the lead due to a change in wire position.The issue has not yet been resolved as the patient is scheduled for a lead revision on (b)(6) 2022.
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Manufacturer Narrative
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Continuation of d10: product id 978b128 lot# va2mx30 implanted: (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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Event Description
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Additional information was received from the manufacturer representative (rep).They reported that the issue had been resolved as the patient had been re-implanted during lead revision and the patient was getting therapy.
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Manufacturer Narrative
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Continuation of d10: product id 978b128, lot# va2mx30, implanted: (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 978b128 lot# va2mx30 implanted: (b)(6) 2022 product type lead.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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