MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number ADDRL1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiomyopathy (1764)
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Event Date 03/14/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced non-ischemic cardiomyopathy and pacing induced cardiomyopathy was suspected.The device 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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Continuation of d10:977a260 pain stim lead; 97714 pain stim ipg implanted on (b)(6) 2014.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.Analysis of the device revealed normal battery depletion.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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