Model Number NEU_INS_STIMULATOR |
Device Problems
Component Missing (2306); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 04-feb-2023, 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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It was reported that there was abnormal impedance during the lead implant procedure and the lead cap was missing a screw.The surgery was completed by using a different lead.The patient was hospitalized for observation after the implant procedure.
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Manufacturer Narrative
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B1/h1: initial report incorrectly reported this event for serious injury.Additional review indicated there was no evidence the patient was hospitalized as a result of the event, nor that the post-procedure hospitalization was prolonged as a result of the event.The event is still reportable for malfunction.Section d information references the main component of the system, other applicable components are: product id 3387s-40 lot# va27sw9 serial# implanted: explanted: product type lead product id 924256 lot# 082210420a serial# implanted: explanted: product type accessory h3: the returned lead (lot # va27sw9) was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.The returned stimloc burr hole cover (lot # 082210420a) was subjected to a series of standard tests that include but is not limited to visual inspection and functional testing.Analysis identified that a part (screw) was missing from the stimloc kit.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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Search Alerts/Recalls
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