Model Number 37800 |
Device Problems
Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
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Patient Problems
Electric Shock (2554); Insufficient Information (4580)
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Event Date 04/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 03-oct-2020, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 31-aug-2020, 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 via manufacturer representative who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient was experiencing shocking.They had a physical altercation with their family post-op and had not had the shocking sensation prior to that event.An interrogation of the stimulator was performed on (b)(6) 2021.The setting was turned down to 2.5 volts from 8.0 volts and the patient could no longer feel sensation.The issue was resolved at the time of the report.They planned to have an x-ray that same day to verify the lead location/confirm lead placement.If the patient experienced shocking again, the device would be turned off completely.The patient's gastroenterologist ordered an anterior/posterior x-ray which¿showed the leads were no longer in the correct position.The patient was scheduled to see a surgeon soon for a consult and possible revision of the entire system would be discussed.The physician suspected the leads were initially dislodged during the physical altercation post-implant.The patient discussed the altercation with staff as the possible cause.Additional information was received from a manufacturer representative (rep).The rep reported that the physical altercation post-op was not in reference to their implant procedure from (b)(6) 2019.They reported, "a physical altercation, a fist-fight, post-surgery." the patient had admitted to being in a physical fight a few months after the device was placed.To quote the patient, the event occurred, "a few months after the implant procedure." the exact date was unknown.When asked to clarify whether the lack of sensation was in regards to a lack of shocking sensation or lack of stimulation sensation, the representative replied that patients do not typically feel any sensation from the gastric therapy.The fact the patient was complaining of "shocking" was irregular.In the clinic, when the voltage was decreased, the patient no longer felt any shocking or sensation from the device.The patient was sent for an anterior/posterior x-ray to determine further what the issue may have been.Once the x-ray confirmed the lead was no longer located where it was originally implanted, and the patient admitted to the physical altercation, the hypothesis was made that this was probably the event that pulled the leads out of the muscular wall of the stomach.The issue was not yet resolved, and as previously noted, the patient had been referred to a surgeon for a revision of all components.The surgeon had to have a consultation with the patient first, and then surgery would be planned at the surgeon's discretion.The system was off and the patient was no longer feeling any sensation or shocking.Additional information was received from a manufacturer representative (rep).The rep reported that the patient was scheduled to have a revision of all components on (b)(6) 2021.
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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 manufacturer representative (rep).The rep reported that there were no device related issues, it was presumed that leads were dislodged due to patient altercation post-operatively.No further complications were reported/anticipated at this time.
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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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Search Alerts/Recalls
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