Model Number 37800 |
Device Problems
Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)
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Event Type
Injury
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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 unknown indications for use.It was reported that they have had 3 but unfortunately, it did not help them with their symptoms.The patient stated that the gtube got tangled with the leads and they have to have it removed and had to pack the whole in their abdomen until it was heal.
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Manufacturer Narrative
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Continuation of d10: product id neu_unknown_lead lot# unknown product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.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.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: patient information was missing from initial report.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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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 patient.They reported that this issue took place with their most recent device, which was explanted approximately 1.5 years after implant.They had the device in place for about 1.5 years, and the device site was completely healed with no issues.The patient (pt) also had a g-j tube.The g tube went to their stomach, and the j-tube to the jejunum.There was a granuloma around the j-tube (unrelated to ins implant) that they had to treat with silver nitrate.After 2 of those treatments the scar site for the ins implant started turning red.(ins scar was about 4 inches above the j-tube).The right side of the ins scar started to blister, became infected and the entire device was removed by the hcp.They had to pack the explant site for 6-8 weeks before it healed.That explant site is completely healed now.Pt wanted another ins device because it helped with their bile reflux, however hcp thought it was an infection risk with the j-tube.Hcp couldn¿t explain correlation between silver nitrate treatment to the j-tube with infection to the implant site, and that may have been unrelated.
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Search Alerts/Recalls
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