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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL TREMOR
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| Model Number B35200 |
| Device Problems
Failure to Interrogate (1332); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
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| Patient Problem
Paresthesia (4421)
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| Event Date 12/08/2020 |
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Event Type
Injury
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Manufacturer Narrative
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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 the implantable neurostimulator (ins) was not responding after the patient had cardioversion, synchronized 200 joules.There was telemetry issue with the ins.The patient was turned off by another manufacturer representative (rep) earlier today.The caller went to turn the ins back on.The tablet connected to the communicator but was not communicating with the ins, yellow amber light blinking on the communicator.They had another communicator to try, which also was not communicating with the ins.The patient's handset was not available.Due to multiple attempts, it was recommended to try another tablet.It was also reviewed how to reset the ins and to begin talking to the ins, they may need to reset the programming.They tried another tablet but had the same result no device found.The rep used their tablet to reset the ins, attempted to communicate to the ins with the communicator over the implant, got communication in progress then a message saying "invalid access group, no active groups on device, would you like to activate a group", and the rep picked group a.There was no device response and the communicator kept beeping, stopped at 80, and would not talk anymore.The rep hit cancel and retried again.They tried to connect, gave option and the rep picked find previous device.Then, it began searching for the communicator, the device connected but the communicator was not found.The rep shut everything down, tried again, and had communication failure ended session.They tried communicating the ins again without the communicator over the implant, saw orange light on the communicator, searching for device, and got nothing.They reset the ins a second time.Another time still showing communication in progress, stopped at 77-80% and provided message about invalid group.Telemetry failure and end session.They tried to talk again with the usb cable and communicator but the actions were still the same with no response from the ins, just stuck on searching for device.The patient reported feeling tingling but tremors did not seem bad.They replaced the batteries in the communicator, retried again, and came back with message looking for valid group.
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Event Description
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Additional information was received reporting multiple interrogations, multiple resets of the ins, communication with the patient's pp with none of these steps leading to the ins being able to become functional at this time.They connected to the communicator, connected to the ins, the orange light was on then off.They used sleeve with the communicator and there was no communication using bluetooth.They clicked connect and got searching for device pinwheel but no response from the ins.First device reset, they interrogated device, got pinwheel, cancelled out, and had no response from device.They interrogated with communicator using usb, connected, searched for device, but was cancelled out/no response.They reset the ins again and it was still not connecting.They forced stopped communication manager, reconnected to the ins, and got searching for device and spinning.They retried interrogation, placed the communicator more horizontal and palpated the ins.They ensured the connector was connected.It came back to the reset page but there was no beep with the third ins reset.They rebooted the app, unplugged/replugged in the communicator, reset the ins, heard a beep and now have communication in progress.They got "invalid active group:" message.They chose to end session.They reconnected, searched for device and cancelled session.The patient reported some tingling and has their remote.They tried with the patient programmer (pp), asked to connect, searching for device with no device response.They reset the ins, heard beep on the communicator, rebooted the pp and communicator, retried but got no device response.The links showed the ins is linked to the handset.They connected to the ins with the clinician programmer app, unplugged/replugged usb cable, turned off/on the communicator, shut down the app and turned it back on.They pressed connect, searching for device and cancelled that interrogation.The bottom of the tablet was hot.The extension is across the chest.The left side: newest extension from right side over chest to left ins.The last ins reset, they heard a beep, closed out, connected to the ins, searching for device, communication in progress, status bar 70, got "invalid active group: choose clear therapy", communication at 80% and no device response.They moved the communicator around in small increments to see if it connects and the patient reported feeling tingling.They cancelled and gave it 30 seconds.During the call, it was noted that they can palpate the side by the incision but it does goes deeper.The patient has a 1x4 adaptor implant.The cardioversion was on front and back.They were instructed to place it perpendicular.
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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.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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Manufacturer Narrative
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Destructive analysis determined that there was abnormal function of an integrated circuit on the hybrid circuit board of the implantable neurostimulator (ins).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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Additional review indicates that information from manufacturer¿s report #3004209178-2021-07206 was already reported in this report, 3004209178-2020-21520.Any additional information regarding this event will be submitted as a supplemental submission to this report.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 that only the implanted neurostimulator was replaced.Caller reports based on the x-ray, the poc ket adaptor was still implanted.
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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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