MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Burning Sensation (2146)
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Event Type
malfunction
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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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Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that sometime between 2020-2021 patient experienced burning sensation at the ins site which lasted for about 15 seconds and happened randomly.Patient said sometimes would also feel the burning sensation in the left buttock, same side as ins.Patient said that they notified their managing hcp a year ago about this issue and was told to notify the hcp when it becomes more frequent.Patient said that it happens more frequently now and also for longer, for about 5-10 minutes.Patient said that today they saw their managing hcp about this and was redirected to call medtronic.When asked, hcp didn't perform any diagnostics.Patient said that the hcp mentioned something about upgrading to a new model.Patient said they've turned stimulation off for a short period of time and also turned stimulation down and stated that they still felt the burning sensation.When asked, patient has had no falls or trauma.The caller was redirected to schedule an appointment for a device check.Patient services sent email to field staff with request to follow up with hcp office regarding scheduling appointment to check patient's device.
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Search Alerts/Recalls
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