Model Number 37800 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problems
Abdominal Pain (1685); Abdominal Distention (2601)
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Event Date 10/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is approximate.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 who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient report that two months ago started experiencing abdominal pain, said related to gastroparesis.Patient said that saw managing hcp and the local manufacturer representative (rep) was present and patient was told that ins battery is low.Patient said that knows that it was set to the highest setting however has had the implant for less than a year.Patient said that the rep told him that patient has 3 months in order to replace.Patient said has been hospitalized for the past 3-5 days for abdominal pain and would like rep to come and check ins battery again.Patient said would like his regular hcp to have equipment.Additional information was received from a consumer via a manufacturer representative.It was reported that he believes pt is getting an early depletion of his ins.Rep wanted to see if expected longevity could be calculated as pt has only had battery around 9 months.Rep provided the following settings: current battery voltage: 2.575volts impedance 591 ohms amplitude 8v current 13.5ma pw 370 rate 55hz on 3s off 2s.Tss referenced the longevity estimation table on pg.22 of the enterra ii implant manual and reviewed that the reported settings, though not an exact calculation, seem to be in line or close to with what the reported longevity is.Tss recommended reviewing this table with the clinician if needed and discuss potential programming changes at hcp's discretion to allow for increased longevity.Managing hcp is (b)(6).The rep additionally reported patient was having pain and bloating in their stomach.No external factors were listed and the following device info was provided.Battery indicator: battery needs to be replaced.Battery voltage: 2.575.591 ohms.Voltage:8 volts.Current: 13.5.Pulse width:370.Rate 55.On:3.Off:2.They are planning to have the device replaced.The issue was not resolved the time of this report.
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Event Description
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Additional information was received from a manufacturer representative (rep).The rep reported that the patient is programmed to high levels of energy.Based off the battery depletion and setting is normal, 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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Manufacturer Narrative
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Upon further review, information submitted in report 3004209178-2022-01724 should be documented with this event as its related.Information is now attached in this report, see b5.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 a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient reports battery depleted in less than a year and is inquiring why.Agent reviewed longevity with high settings can result in less than 1 year longevity.Pt states device depleted 2 weeks ago and was implanted with a new device.Documented reported event.No further action was taken by patient services.
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Search Alerts/Recalls
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