MEDTRONIC PUERTO RICO OPERATIONS CO. ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number A2DR01 |
Device Problems
Signal Artifact/Noise (1036); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during the implantable pulse generator (ipg) change out procedure, the right atrial (ra) lead exhibited noise before the procedure due to an incomplete fracture on the lead and high, undefined impedance was noted after the device was replaced.Lead failure was suspected.Incomplete disconnection was suspected before the changeout procedure, the lead was programmed off and remains in patient.The ipg was replaced due to reaching normal battery depletion.No 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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