MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Human-Device Interface Problem (2949); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 3093-33 lot#: v941222, implanted: (b)(6) 2012 explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 3093-33, serial/lot #: (b)(4), ubd: 09-feb-2016.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 an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that dr explanted the patients device today and said the lead slipped out of the battery header without unscrewing the set screw.
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Manufacturer Narrative
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H3: the returned ins was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing; however the setscrew was backed out too far.The returned lead was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Electrical testing of the lead determined that continuity was complete and there were no electrical shorts between the circuits; however, the lead was not completely seated in the implantable neurostimulator (ins) connector port.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 a healthcare professional (hcp).The hcp reported that the suspect cause of the lead slipping out of battery header was a manufacturer defect and the lead was removed completely and the expired ins battery was removed.The lead just slipped out of the hosing despite continuity to screw down and tightening.No further complications were reported/anticipated at this time.
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Event Description
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No new information for event description.
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Manufacturer Narrative
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H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing; however the setscrew was backed out too far.Continuation of d10: product id 3093-33 lot# v941222 serial# implanted: (b)(6) 2012 explanted: (b)(6) 2021.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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