MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Failure to Deliver Energy (1211); Difficult to Remove (1528); Material Deformation (2976)
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Patient Problems
Sepsis (2067); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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Event Date 05/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id 3889-28, lot# va1z6nr, implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(6), ubd: 02-apr-2023, udi#: (b)(4).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.
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that patient wasn't experiencing therapy results and couldn't feel stimulation sensation even at the highest setting.Patient said that sometime in 2019 (before 2020) they had a surgery to remove by a different doctor in (b)(6).Patient said that the surgeon removed the neurostimulator however did it wrong and the lead became all tangled up and wasn't removed.Patient said that the skin in the area has a lot of bacteria or something that is accumulating and causing a lot of issues: can't walk, a lot of utis and kidney issues and sepsis.Patient said had x-rays afterwards and another physician said that the lead is all coiled up.Patient said having difficulty finding a physician to remove said has consulted with several, however, said that it needs to be removed that the infectious disease doctor stated that it needs to be removed.The patient was redirected to their healthcare provider to further address the issue.At the end of the call patient said does have an appointment with another physician to consult regarding removing the lead.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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