MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTPA2QQ |
Device Problem
Misconnection (1399)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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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 right ventricular (rv) lead extraction, due to the deformation of the part that fits in the main unit cavity of the lead, a stronger force than usual was required when removing, so the lead did not come off under normal force when removing from the cardiac resynchronization therapy defibrillator (crt-d).A rv lead connection failure was indicated.The crt-d was explanted.Additionally, when connecting the rv lead to the new crt-d a blue marker required stronger pressure than usual until it could be confirmed.The rv lead remains in use.The new crt-d remains in use.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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