|
MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
|
Back to Search Results |
|
| Model Number B35200 |
| Device Problems
Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896)
|
| Patient Problem
Memory Loss/Impairment (1958)
|
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
Information references the main component of the system.Other relevant device(s) are: product id a620, serial# unknown.Product type software product id tm91d0.Product type 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.
|
| |
|
Event Description
|
|
It was reported that patient (pt) said they normally turn stim off at night and back on in the morning.Pt said they were not sure the date when their issue started, but for the last 3 nights, they have not been successful to turn stim off at night like they normally do, they have been unsuccessful to connect, it gets to 71 then does not want to connect and communication in progress is really slow and never goes to off it stays on.Pt said they spoke with the manufacturer representative (rep), earlier today they did a lot of troubleshooting, they held the power button down on the communicator for 45 seconds and restarted the handset but were still not successful and rep told the pt to call and say the handset and communicator need to be replaced.Troubleshooting during the call included: power down and back up the handset and connect to their communicator.Pt placed the communicator over their ins (pt said they can feel their ins) and connected to see therapy on, they tried to turn stim off by tapping on off and continue, pt said they felt a wave in their brain like it is trying to turn off but it does not turn off, (pt confirmed they normally get a little bit of electrical feeling in their brain when turning stim off/on).Pt said the screen shows: no device response and it kept going back and forth.Worked with pt to remove the communicator, close open apps on the handset and try again to connect.Pt was successful to connect and reported therapy was on, pt was holding the communicator over their ins, pt attempted to turn stim off but reported no device response again.Consulted with tech support and then worked with pt to connect again.Pt was successful to connect, pt navigated to their therapy setting, their left side was 1.8 their right side was 2.3, they were successful to reduce the right side to 2.2 and back up to 2.3.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue and reviewed this is something that should be checked in person by the doctor and rep.Pt has their regular appointment coming up in april.The patient's relevant medical history included pt stated they used to get a big whoosh of electricity when turning stim on/off but they've noticed it has not been doing that as much and the patient thought maybe they've forgotten or they forgot to turn stim off they have really bad memory issues.Additional information received from the manufacturer¿s representative (rep) reported they attempted to interrogate the implant with the physician¿s tablet and it kept spinning on ¿searching for device¿ screen.The rep attached the tablet to the communicator with the cord but received the same result.The rep used their personal tablet to attempt to interrogate the implant but received the same ¿searching for device¿ scree and it wouldn¿t connect to the implant.The rep successfully interrogated the implant with the patient¿s handset and communicator and were able to decrease and increase amplitude.When the rep attempted to turn the implant off the handset displayed ¿no device response.¿ the rep used the handset to see the patient could decrease to 0.0 ma.The consumer mentioned when the rep attempted to connect with the implant with tablet or turn it off, they could feel something and if they attempted telemetry repeatedly, the sensation they felt would become even more pronounced.The consumer repeatedly attempted to turn the implant off last week they had a horrible headache that lasted all night long and into the next day.In addition, the handset/communicator took a while to connect or sometimes didn¿t connect at all, and didn¿t connect at all for a long time.The rep later confirmed the patient¿s programmer was able to connect to their implant.
|
| |
|
Event Description
|
|
2022-mar-23 rtg0284645 (con): it was reported that patient (pt) said they normally turn stim off at night and back on in the morning.Pt said they were not sure the date when their issue started, but for the last 3 nights, they have not been successful to turn stim off at night like they normally do, they have been unsuccessful to connect, it gets to 71 then does not want to connect and communication in progress is really slow and never goes to off it stays on.Pt said they spoke with the manufacturer representative (rep), earlier today they did a lot of troubleshooting, they held the power button down on the communicator for 45 seconds and restarted the handset but were still not successful and rep told the pt to call and say the handset and communicator need to be replaced.Troubleshooting during the call included: power down and back up the handset and connect to their communicator.Pt placed the communic ator over their ins (pt said they can feel their ins) and connected to see therapy on, they tried to turn stim off by tapping on off and continue, pt said they felt a wave in their brain like it is trying to turn off but it does not turn off, (pt confirmed they normally get a little bit of electrical feeling in their brain when turning stim off/on).Pt said the screen shows: no device response and it kept going back and forth.Worked with pt to remove the communicator, close open apps on the handset and try again to connect.Pt was successful to connect and reported therapy was on, pt was holding the communicator over their ins, pt attempted to turn stim off but reported no device response again.Consulted with tech support and then worked with pt to connect again.Pt was successful to connect, pt navigated to their therapy setting, their left side was 1.8 their right side was 2.3, they were successful to reduce the right side to 2.2 and back up to 2.3.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue and reviewed this is something that should be checked in person by the doctor and rep.Pt has their regular appointment coming up in april.The patient's relevant medical history included pt stated they used to get a big whoosh of electricity when turning stim on/off but they've noticed it has not been doing that as much and the patient thought maybe they've forgotten or they forgot to turn stim off they have really bad memory issues.2022-03-28 rtg0284645 update (rep): additional information received from the manufacturer¿s representative (rep) reported they attempted to interrogate the implant with the physician¿s tablet and it kept spinning on ¿searching for device¿ screen.The rep attached the tablet to the communicator with the cord but received the same result.The rep used their personal tablet to attempt to interrogate the implant but received the same ¿searching for device¿ scree and it wouldn¿t connect to the implant.The rep successfully interrogated the implant with the patient¿s handset and communicator and were able to decrease and increase amplitude.When the rep attempted to turn the implant off the handset displayed ¿no device response.¿ the rep used the handset to see the patient could decrease to 0.0 ma.The consumer mentioned when the rep attempted to connect with the implant with tablet or turn it off, they could feel something and if they attempted telemetry repeatedly, the sensation they felt would become even more pronounced.The consumer repeatedly attempted to turn the implant off last week they had a horrible headache that lasted all night long and into the next day.In addition, the handset/communicator took a while to connect or sometimes didn¿t connect at all, and didn¿t connect at all for a long time.The rep later confirmed the patient¿s programmer was able to connect to their implant.
|
| |
|
Manufacturer Narrative
|
|
Continuation of d10: product id a620 lot# serial# unknown implanted: explanted: product type software product id tm91d0 lot# serial# unknown implanted: explanted: product type 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.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Event Description
|
|
Additional information received from a rep indicated that during a follow-up meeting with the patient on 07 april, the tel-m application was able to successfully connect to the ins via tm91.The patient's ins was able to be reset using the tel-m ins reset command.After the reset, the a610 and a620 applications were able to successfully communicate with the patient's ins, and the patient's stimulation settings were confirmed.
|
| |
|
Event Description
|
|
Additional information received from the manufacturer¿s representative (rep) reported the programmer was able to connect with the implant.The consumer mentioned they would prefer to turn the device off if possible as their disease had progressed, and they experienced headaches after trying to turn the device off.The patient was scheduled to meet with their physician on april 4th where they were going to make sure their patient limits were set to allow them to go down to zero.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Event Description
|
|
It was reported that the manufacturer representative wasn't able to interrogate the patient's implant and kept getting a "searching for the device" screen.The rep said the patient can connect their handset to the implant but can't turn therapy off for the last 3 nights.Technical services(ts) sent a message to the engineer to coordinate a reset.The implant issue is likely related to fa1231.Update software to: 1.0.1213 com.Manager 3.0.1098 a610 5x405fa feature code.The issue was not resolved through troubleshooting.Additional information was received.An engineering team met with the patient on october 18, 2022.The device was rest and was then able to successfully connect to the ins via communicator.Logs were received.The patient's ins was able to be reset using the tel-m ins reset command.After the reset, the clinician and patient applications were able to successfully communicate with the patient's ins, and the patient's stimulation settings were confirmed.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Event Description
|
|
Additional information was received.An engineering team met with the patient on october 18, 2022.The device was rest and was then able to successfully connect to the ins via communicator.Logs were received.The patient's ins was able to be reset using the tel-m ins reset command.After the reset, the clinician and patient applications were able to successfully communicate with the patient's ins, and the patient's stimulation settings were confirmed.
|
| |
|
Search Alerts/Recalls
|
|
|
