MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number B35200 |
Device Problems
Break (1069); Insufficient Information (3190)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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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 the entire dbs system will be explanted on (b)(6) 2024.The reason is not known.Additional information was received from the manufacturer representative (rep) that it's believed the treatment is affected by the problem with the device.Additional information will be available april 15th.
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Event Description
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Additional information was received from the rep that on april 15, an operation was performed to remove and re-place the lead, and it was confirmed that this event was caused by the lead fracture.
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Manufacturer Narrative
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Continuation of d10: product id 3389s-40 lot# va2fdeq, product type lead product id 3389s-40 lot# v a2fdeq serial# product type lead product id 3389s-40 lot# va2fdeq serial# product type lead product id 3708660 lot# serial# (b)(6) , product type extension product id 3389s-40 lot# va2efuf , product type lead product id 3708660 lot# serial# (b)(6) ,implanted: explanted: product type extension.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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