Model Number 3116 |
Device Problems
Battery Problem (2885); Data Problem (3196)
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Patient Problem
Nausea (1970)
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Event Type
Injury
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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 gastric stimulation.It was reported that for the first 4.5 years, the therapy worked well, however in the past 2 or more years, they reported having experienced more nausea and had more frequent doctor's appointment to adjust the settings.The patient stated that the health care professional (hcp) staff performing the programming commented several times that the setting was changing between appointments and that the neurostimulator battery was depleting.The patient said on an appointment on (b)(6) with the nurse practitioner, the battery was at 7.6 and on (b)(6), the battery was at 2.6.The patient said that during this time they were prescribed zofran.The patient said that they had their first consult with a surgeon yesterday and asked about implant procedure, whether the lead would be replaced and said that the surgeon had flatly said only the neurostimulator and wouldn't provide any further information.The patient said they reviewed information on the manufacturer company's website about the surgery and wanted to review the information.The patient services agent consulted with the stimulation technical services agent regarding replacement procedure.The patient services agent reviewed impedance testing that was performed during the standard programming sessions and that if there was a concern, then the managing hcp would provide this information to the surgeon.Patient services also explained that after the new neurostimulator was connected, an impedance test was typically performed to check the leads.The patient said that their neurostimulator battery replacement procedure was scheduled for (b)(6) 2021. the patient was redirected to their healthcare provider to further address the issue.Patient services also reviewed the option of the patient asking the scheduling office if the local manufacturer representative (rep) was going to be present and that patient could request that the hcp office notify the rep of the procedure date to check availability.
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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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Additional information was received from the patient.The patient stated that the healthcare provider (hcp) thought that the battery power was decreasing.The device was replaced on (b)(6) 2021.The patient has not been able to see the hcp since the surgery.Their next appointment is on (b)(6) 2022.No further complications were reported.
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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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