MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_INS_STIMULATOR |
Device Problems
Connection Problem (2900); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
Event Type
malfunction
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Event Description
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Information was received from a patient's representative regarding an external device.The caller had a broken desktop charger connector pin 37761.An email was sent to repair to replace the desktop charger.No symptoms 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: 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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Continuation of d10: product id 37761 lot# serial# (b)(6) product type recharger h3: analysis of the desktop charger (serial number (b)(6)) revealed a frayed cord.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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