Model Number B35200 |
Device Problems
Failure to Interrogate (1332); Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: a620, serial#: unknown, product type: software.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from the manufacturer¿s representative (rep) who reported they tried to link the handset to the neurostimulator and got system error code 0x3e100894.The rep attempted three times with restarting the application.It was suggested to power down the handset and communicator and try again.The rep called back later that day and reported they were still experiencing the same issue system error code 0x3e100894.The rep confirmed they were able to communicate fine with the tablet.The communicator was reset, but the same issue occurred.A different handset was then used, and the same error code occurred.It was confirmed the tablet worked fine.Shortly after, the rep called back after trying a new communicator and handset and the issue still occurred.
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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.
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Event Description
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Additional information was received.During patient's follow-up visit, settings were programmed and therapy was turned on.The patient would have normal follow-up appointments with the physician, per normal follow-up with deep brain stimulation (dbs) patients.
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Event Description
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Additional information was received which clarified that "battery off" referred to stimulation being turned off.The patient was newly implanted with the implantable neurostimulator (ins).It was reported that sending the patient home with sensing enabled and stimulation off was a decision made by the physician.This was reportedly consistent with the physician's standard of care for newly implanted patients.The decision to send the patient home with stimulation off was not related to the communication issue.
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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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Section d information references the main component of the system.Other relevant device(s) are: product id: a620, product type: software, serial/lot #: n/a, software version: 2.0.1773, ubd: n/a, udi#: (b)(4).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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