MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTPA2Q1 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/05/2023 |
Event Type
Injury
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Event Description
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It was reported that elevated thresholds, high thresholds, and a sudden rise in thresholds were observed on the left ventricular (lv) lead.The lv lead was reprogrammed.It was further reported that the lv lead continues to exhibit elevated and high thresholds and the lead was again reprogrammed and remains in use.Additionally, it was noted that the cardiac resynchronization therapy defibrillator (crt-d) exhibited decreased battery longevity due to the elevated thresholds.The crt-d was reprogrammed and remains in use.The patient is a participant in a clinical study.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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