MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problems
High impedance (1291); Migration or Expulsion of Device (1395); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Unspecified Infection (1930)
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Event Date 02/27/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id: 3387s-40, serial#: (b)(6), implanted: (b)(6) 2010, product type: lead.Section d information references the main component of the system, ubd: 25-aug-2012, 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 patient (pt) reported efficacy however, per examination it appears both leads are exposed at scalp and impedances are consistently out of range - all per healthcare provider (hcp).Patient caregiver (daughter) does not want to remove due to efficacy but md office recommending surgery to remove due to potential infection and obvious impedance issues.Per np: ran impedances at high powers.Rstn monopolar off at 8.9.10.11.All over 5000.Bipolars off at contacts 10 & 11.Lstn monopolars over 2000 at contacts 2 & 3.The issue was not 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.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 the healthcare provider (hcp) reported it was unknown if there was an infection or whether a cause was determined.The patient was refereed to their neurosurgeon.
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Search Alerts/Recalls
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