Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the reason for the call was that the patient reported they just found out their implant battery was dead after only 13 months.The patient reported this implant was their sixth one, and that each implant lasted about two years until they depleted normally due to the high settings the patient used, however, this implant was at a slightly lower setting than the other implants.The patient reported their typical symptoms were that they would have intermittent nausea once or twice a month that would resolve on its own, however, on (b)(6) 2021, they received their first covid vaccination and after that shot, they could tell they started to experience their symptoms a little bit more.The patient then went to get their second covid vaccination on (b)(6) 2022, and that was when their symptoms really started to get worse and they were put on a medication.The patient stated they typically weighed (b)(6) pounds, however, they lost (b)(6) pounds from (b)(6), so they went to see their managing health care provider (hcp) who increased the setting at that time.The patient reported they had been especially ill since sunday (b)(6) 2022), and they were just checked by their hcp on thursday ((b)(6) 2022).The patient wanted to know what could make their battery deplete in 13 month's time and inquired if their smart watch could affect the battery longevity.The manufacturer help line reviewed this information.The patient also mentioned that on (b)(6), before they could even tell a security guard to avoid "wanding" their implant, the guard wanded over the implant.The patient wanted to know if that could have turned the implant, or if it could have depleted the battery more quickly.The manufacturer help line reviewed that from what the manufacturer knew of their products, the wanding incident would not be expected to drain the implant battery more quickly than usual or turn the implant off.The patient was going to follow up with their hcp to schedule a replacement surgery.The analysis process was reviewed with the patient.They were redirected to follow up with their healthcare provider.
|
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.
|