Model Number 97714 |
Device Problems
Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins).Caller reported patient stated the ins is turning off on its own.The patient checks and the stim is off.Caller checked and the date was wrong for the ins.Caller adjusted the date and will review stats at a later date.Technical services reviewed ins can turn off once the ins is depleted.Patient will document any time that therapy is lost and shows stim off.They will meet back at a later date.
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Event Description
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Additional information from the rep indicated that when the programmer was initially set up, it had the incorrect day and time.It was not determined what caused the stimulation to be turned off or if it actually was ever turning off or if the issue was fixed from the last time they saw the patient.They set the correct day and time so that they could see the therapy events log; they educated the patient extensively regarding the re-charge process and that therapy can be turned off if the device is not charged.They have not been able to get in contact w the patient regarding an update surrounding the issue.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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