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Model Number X3DR01 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2024 |
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 during the implant procedure of the implantable pulse generator (ipg), the screw driver was damaged.The screw and screwdriver slipped when screwed in, making it impossible to safely fix the atrium and ventricular lead into the pacemaker.The ipg was attempted, not used and was replaced. hospitalization was required as a result of the event.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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