MEDTRONIC SINGAPORE OPERATIONS AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number W1DR01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Hematoma (1884); Discomfort (2330); Swelling/ Edema (4577)
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Event Date 03/11/2024 |
Event Type
Injury
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Event Description
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It was reported that approximately ten days post-implant of the implantable pulse generator (ipg) system, the patient developed hema toma.Treatment was initiated with antibiotics over a course of ten days.The pocket was subsequently infected and patient was presented with discomfort, swelling and wound dehiscence.Infection was localized to the pocket.Hematoma cultures revealed staphylococcus epidermidis.Organism of the infection was staphylococcus aureus.The ipg system was explanted and replaced.No further patient complications have been reported as a result of this event.
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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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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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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