Model Number 37800 |
Device Problems
Intermittent Continuity (1121); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
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Patient Problems
Abdominal Pain (1685); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Cramps (2543); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 09/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor and gastric stimulation for gastroparesis.It was reported that the patient began feeling abdominal pain/cramping at the pocket site with waves of shocking (like a cattle prod).The healthcare provider saw the patient in the emergency room (er), and after speaking to a doctor, they suggested turning the p atient's device down.The voltage was turned down from 2.5 volts to 1.2 volts, and they suggested they would see the patient in their office once they were discharged.The patient went to the emergency room on (b)(6) 2021 as well, and they did a computed tomograph y (cat) scan, which appeared normal.Their impedance was 438 ohms.It was unknown if there were any environmental/external/patient factors that may have led to or contributed to the issue.The issue was not resolved at the time of the report.No surgical intervention occurred and none was planned.The patient also reported they had just moved and could not find a doctor who was familiar with their stimulator.They believed it may be misfiring or malfunctioning.It felt like an electric shock on the upper left side, and was a level ten on a pain scale, with side and back cramping, nausea, vomiting, and a low grade fever at 100.1 degrees fahrenheit.They had been to the emergency room twice, but they said there was nothing they could do for them because all the labs looked normal and the stimulator was in place.The patient was sent physician listings.
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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 the doctor moved the patient's battery to a different site due to pain on (b)(6) 2021.
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Event Description
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Additional information was received from the hcp.It was reported that the doctor removed their implant on (b)(6) 2022 due to pain.
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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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