MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problems
Failure to Interrogate (1332); Device Difficult to Program or Calibrate (1496); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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It was reported that no telemetry could be established with a percept pc implanted in a patient. the physician tried to use multiple tablets with no success.All the tablets were installed with the latest applications.The scope of the interrogation was to do some minor adjustment to the stimulation.However, overall the patient is doing well with the current settings. the patient has no symptoms return, strongly suggesting that the percept pc is working as intended.No external or other factors were reported.The physician tried to interrogate the ins with different tablets with no success.All the tablets were updated with the last app versions.The first tablet used was the same used in the last follow-up in october 2023.Additional information was received from the rep that they tested telemetry with their own device and was not able to interrogate the device.However, the patient brought his patient programmer and it was still possible to communicate and establish connection with ins.
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Search Alerts/Recalls
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