MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Break (1069); Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Seroma (2069); Device Embedded In Tissue or Plaque (3165)
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Event Date 06/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 978b128, lot#: unknown, implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: lead.The main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: unknown, ubd: unknown , udi#: 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.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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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the surgeon most concerned about the seroma that developed over the ipg after both of the procedures this patient needed.In the first instance the seroma was symptomatic, and was analyzed to find a negative culture.The second procedure, to replace the lead, the surgeon discovered another seroma, and identified a pre existing allergy to tetracyclines, and identified that tyrx is not indicated in this instance.Thought were that the tyrx may have caused the seromas.Lead migration was identified with radiology. all items were explanted due to allergy. patient developed a seroma within the capsule, that required an operation to drain in (b)(6) 2022, it was symptomatic and had a negative culture.The patient then developed a subsequent seroma around the ipg capsule, identified at the time of change of lead to the new mri compatible lead.Lead fractured between 2 & 3 electrode and 3 electrodes remain in patient.There was a 90 degree bend in the lead which had pulled out from the sacral space.Little detail was provided on how this could have happened.The surgeon decided to remove all components to allow the patient pt to heal.And will arrange a neurosurgeon to get the electrodes out from the pre-sacral space.Prior to placing a new full system.
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Event Description
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Additional information received from a manufacturer representative (rep) stated the cause of allergic reaction was unknown.The issue was resolved and the hcp was notified of the event.
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Manufacturer Narrative
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Continuation of d10: product id 978b128 lot# va2g8f9, implanted: (b)(6) 2021, explanted: (b)(6) 2022, 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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