Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2024 |
Event Type
malfunction
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Event Description
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Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the ins was not charged for over two weeks.The rep tried to charge the ins for about two hours using the type of ¿physician recharge mode¿, but this did not work.The antenna locate (al) function showed a number of 96.It was already tried to disable-enable the ins via the technician mode and tried different recharge antenna¿s and controllers, without success.Based on palpation, the ins seemed to be superficial and parallel to the skin.Additional information was received reporting the diagnostics/troubleshooting performed.Patient could not restart ins after completely depletion of ins.Device is not being found, and when trying to charge ins, only metal detection screen was seen.Following actions were taken: change recharger; change internal battery of patient controller; 3) changed patient controller; 4) go to tech modus in patient controller option 4 - deactivate device and afterwards activate device to activate telemetry of ins.None of the actions resolved the issue.The cause of the event was asked.The ins was recently depleted once again completely, and patient could not start the ins charging session (stayed on metal detection screen).This event will be discussed with the physician to see what the next steps will be.The event was not resolved.
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Manufacturer Narrative
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G2: belgium 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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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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received.An rx was taken but no issues were seen at first sight.The physician is aware of this and will contact the patient to have a follow-up.However, no date was confirmed yet.
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Event Description
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Additional information was received.It was reported that "an rx was taken but no issues were seen at first sight" meant they took an x-ray.They advised the hospital to make an appointment with the patient.However, they weren¿t informed yet if this has already occurred.The actions taken to resolve the issue were that they advised the hospital to make an appointment with the patient and the physician.It was unknown if the event has resolved.
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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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received reported that the rep contacted the physician who mentioned that the appointment did happen and there would be no further actions for this patient due to other, external factors.The rep would schedule a follow-up call with the physician to discuss this further.
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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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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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Event Description
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Additional information received from a manufacturer representative.It was reported that the representative discussed the issue with the physician, and no further actions were to be taken.
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Search Alerts/Recalls
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