MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Break (1069); Entrapment of Device (1212); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 3889-28, lot#: va05j9l, implanted: (b)(6) 2013, product type: lead.Product id: 3889-28, serial/lot #: (b)(4), ubd: 17-dec-2016, 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 a patient's friend or family member regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The healthcare provider (hcp) removed part of the lead, however, the distal part of the lead was embedded in the tissue and could not be removed.No further complications were reported.
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Event Description
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Additional information was received from the patient.They reported that the cause of having part of the lead left embedded in the tissue was unknown, but the most likely cause was a broken lead.It was noted that the issue was not resolved, but no further actions would be taken to resolve the issue.
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Manufacturer Narrative
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H6: codes updated, disregard previous codes.Only the codes captured here are applicable to this file.Concomitant medical products: product id 3889-28 lot# va05j9l, implanted: (b)(6) 2013, 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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