Model Number 37800 |
Device Problems
Break (1069); High impedance (1291); Material Deformation (2976)
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Patient Problem
Twiddlers Syndrome (4563)
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Event Date 02/24/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products : product id: 4351-35, serial#: (b)(4) ,implanted: (b)(6) 2015, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2015.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 27-feb-2017, udi#: (b)(4).Product id: 4351-35, serial/lot #: (b)(4),ubd: 27-feb-2017, 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 gastric stimulation.It was reported that the hcp contacted them because they were planning to replace the ins and when the pocket was opened the leads were knotted up.The caller indicated that he thought the patient had twiddlers syndrome.The caller reported that the md tried to connect the leads to a new ins and the impedances were high at 1733ohms.When the md attempted to unknot the leads one of them broke.Troubleshooting was not required.The issue was not resolved through troubleshooting.The caller indicated that the hcp will plan to explant and re-implant the patient at some point.
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Event Description
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Additional information was received from the manufacturer representative.It was reported that a explant and re-implant date has not been planned as of yet.
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Manufacturer Narrative
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Continuation of d10: product id 4351-35 lot# serial#(b)(6) implanted: (b)(6) 2015 explanted: product type lead product id 4351-35 lot# serial# (b)(6) implanted: (b)(6) 2015 explanted: 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: 4351-35, serial# (b)(6), implanted:(b)(6) 2015, product type: lead; product id: 4351-35, serial# (b)(6), implanted: (b)(6) 2015, 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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Search Alerts/Recalls
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