MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Vibration (1674)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2024 |
Event Type
malfunction
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Event Description
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Information was received from a patient via a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence, urinary/bowel dysfunction.It was reported that rep is calling in to report.Caller reports she had seen patient yesterday in the clinic.Caller reports patient indicated she felt her ins battery was vibration for about 2-3 minutes sometimes the last week of (b)(6) 2024.Caller reports patient reported the vibration only happened once.Caller reports patient is not having any issue with her therapy.Patient indicated the vibration is not coming from her phone or her watch.
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.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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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 on (b)(6) 2024, an impedance check was performed on the implant which showed all electrodes to be in good condition.Pt reports therapy is providing over 50% improvement in her symptoms.There has not been any interruption in her successful therapy.The reported incident happened only the one time while she was sitting in a booth at a restaurant for dinner.The patient will notify the doctor and manufacturer if the incident happens again.
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Search Alerts/Recalls
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