Model Number 37612 |
Device Problems
Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Unstable (1667); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/09/2023 |
Event Type
Injury
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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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It was reported that the wireless recharger (wr) connects to the left implantable neurostimulator (ins) and works fine but will not connect to the right ins.Manufacturer's representative (rep) was not with patient (pt) at time of call so technical services (ts) was unable to troubleshoot.Rep will meet pt. caller reports the wireless recharger was able to connect for a brief second with excellent coupling and then went back to searching for device. caller has reset the wireless recharger and close all history on the handset. continues to connect for a brief second with excellent coupling and then went back to searching for device.Caller reports she tried multiple different position. caller reports this started 3 days ago. patient indicated nothingunusual happened from 3 days ago to now. patient mention he had difficulty connecting the ins to the wireless recharger, but was able to connect eventually. caller reports the wireless recharger was not paired to the handset.Reviewed how to pair the recharging app to the wireless recharger.Caller reports she paired successfully. caller reports she has a spare wireless recharger.Caller reports the spare recharging is doing the same thing: connect for a brief second with excellent coupling and then went back to searching for device. caller reports the ins pocket is loose and can move the device around. caller reports she is seeing message: low battery.Recharge your neurostimulator battery to prevent future loss of therapy.Service code: 626. suggest xray to check for possible flipped right ins. caller reports ins is flipped, physician attempted to flipped manually, was able to charge briefly, but ins flipped again, due to scar tissue, ins would not stay in proper position. caller reports patient scheduled for surgery tomorrow.No symptoms were reported.
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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 received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported on may 13th the device was flipped back to the correct orientation via surgical intervention.Following this the recharging issue resolved.
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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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Search Alerts/Recalls
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