MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
Pain (1994)
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Event Date 12/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 3093-28 lot# va02euc, implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type lead.Other relevant device(s) are: product id: 3093-28, serial/lot #: (b)(4), ubd: 22-aug-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 a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient is experiencing sharp pain in her ribs. the healthcare provider (hcp) had patient turn off the stimulator.The pain went away.When she turned it back on and it hurt her ribs again.The hcp replaced the full system.X-ray did not show any movement of the lead.Upon removal of the lead the hcp noticed the lead had the sheath removed at the portion of where it connects with the ins. patient reported she did have a fall this summer.
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Manufacturer Narrative
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Continuation of d10: product id (b)(6) lot# va02euc serial# implanted: (b)(6) 2012 explanted: (b)(6) 2020 product type lead h3: analysis results not available at the time of this report.An additional report will be sent once analysis is completed.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: 3093-28, lot#: va02euc, implanted: 2012 (b)(6), explanted: 2020 (b)(6), product type: lead, h3: analysis of the ins (s/n (b)(6) and lead (lot# va02euc) revealed that the ins passed functional testing.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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