MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 97800 |
Device Problem
Electromagnetic Compatibility Problem (2927)
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Patient Problems
Arrhythmia (1721); Concussion (2192); Loss of consciousness (2418)
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Event Date 06/28/2022 |
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 urinary/bowel dysfunction and urge incontinence.It was reported that 3 weeks ago patient was at a friend's and passed out.Patient was in the hospital for a couple days.Patient had 2 mris and a cat scan.Patient wore a heart monitor for a week and it showed the patient has irregular heart beats.Patient said the ins was on while they were wearing the heart monitor.Patient said everything is not explained in the books.Patient said the video doesn't mention having to turn stim off for some medical procedures.Reviewed the effects of monitoring devices with patient.Patient said they didn't have heart issues before they got the device.Patient said they are going to have the device removed.Patient said it is not fair to have to bring external devices with and turn ins off.Patient was escalated and ended the call.
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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 the patient.They reported that they passed out in (b)(6) 2022, hit their head, and got a concussion.Patient was sent to a cardiologist.Patient wanted to know what the compatibility for a heart holter monitor was.They wore one in (b)(6) 2022.It was attached to their chest and they didn't shut off their stimulator.They did pick something up on the monitor.Patient is seeing a doctor next week.Troubleshooting reviewed the guidelines that if the stimulator was not shut off, the heart monitor could pick up the stimulator pulses and count it as an electrical signal.Patient demanded the information for prescribers document be emailed to them so they can take it to the doctor tomorrow.Patient refused to provide the doctor's name with the most information about the issue with the heart monitor.
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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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