MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_INS_STIMULATOR |
Device Problems
Impedance Problem (2950); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/16/2024 |
Event Type
Injury
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Event Description
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It was reported that the extension connector was in poor contact and the impedance could not be measured.A new extension was replaced to complete the surgery on the same day and the issue was resolved.No symptoms were reported.
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3708660 (serial: (b)(6)); product type: 0191-extension; implant date ; explant date 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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D10: section d information references the main component of the system.Other relevant device(s) are: product id 3708660 serial# (b)(6).Product type extension h3.Analysis of the extension (s/n: (b)(6)) found that the molded rubber of the extension was cut from the distal end; consistent with explant damage.Electrical testing determined that continuity was complete and there were no electrical shorts between circuits.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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