MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; Stimulator, electrical, implanted, for parkinsonian tremor
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Model Number B35200 |
Device Problems
Break (1069); Failure to Deliver Energy (1211); High impedance (1291)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2024 |
Event Type
Injury
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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: b3400060m, serial/lot #: (b)(6), ubd: 15-mar-2024, udi#: (b)(4); product id: b3300533m, serial/lot #: (b)(6), ubd: 05-may-2024, udi#: (b)(4).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 the patient shows impedance problems on right trajectory, all are high except contact 8.The lead shows an extensive integrity issue affecting all the conductors of the right lead, confirmed both via impedance test and the x-ray images. the connection between lead and extension is located in the neck area.Agent reviewed it is not recommended to place the lead-extension connection in the soft tissues of the neck.The patient experienced a sudden loss of therapy.No environmental/external/patient factors that may have led or contributed to the issue are known.Reprogramming was performed.Additional information was received from the manufacturer representative (rep) that the patient noticed therapy loss a couple weeks ago but cannot define exact date.No cause could be determined.Technical services analyzed the reports and the devices were reprogrammed.The issue has not been resolved and reprogramming did not relief patient complaints.Surgery is planned (b)(6) 2024.
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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 was received from a manufacturer representative (rep) clarifying that the patient experienced less stimulation effect which triggered them to go to the hospital for a check.
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Search Alerts/Recalls
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