MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Electromagnetic Interference (1194); Failure to Interrogate (1332); No Device Output (1435); Battery Problem (2885); Communication or Transmission Problem (2896)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/01/2023 |
Event Type
malfunction
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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 gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that they had a colonoscopy on the first of november and for the first time in 8 years they asked patient to turn stim off.Pt said when they turned it off they did see a low battery picture and after the colonoscopy they could not get it back on again.Pt said they were concerned about their internal battery.Asked patient if they noticed any return of symptoms or change in therapy and patient said things have not been normal since the colonoscopy.Worked with patient to try to synch the programmer to the stimulator and patient reported getting poor communication.Patient removed the programmer batteries and confirmed the battery compartment looked good, put the batteries back in and tried again and reported poor communication again, they also tried without the antenna attached and got poor communication again.The issue was not resolved through troubleshooting.Agent reviewed we will replace the programmer but if they continue getting poor communication they should work with their doctor to check their ins.An email was sent to the repair department to replace the device.The patient mentioned their implanting doctor is gone and there is no one currently in the office.Agent offered and sent physician listings.
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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 called back and stated that they got the new programmer, but it was also not connecting to ins.Patient reviewed what had been discussed previously and that next step was to talk with hcp to check ins battery.Patient will follow up with hcp.
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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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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 the cause of the poor communication with the programmer is unknown, but it is likely due to the fact that device is nearly 8 years old and is most likely defunct.They were able to turn off the device for a colonoscopy, but they cannot turn it on again.Replacing the handheld device did not resolve the issue.They don't know anyone who is trained to use these devices.The issue is not yet resolved.The cause of the low battery picture and not being able to get stim back on was caused by normal battery depletion.They indicated that the manufacturing representatives and themselves assume it was normal battery depletion.They are working on getting their records over to a new office, but don't know if they will be able to help because they aren't in there system.They are wondering if this device is removable.The issue is not yet resolved.
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