MEDTRONIC EUROPE SARL AMPLIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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Model Number DTMB2QQ |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
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 the screwdriver could not engage the cardiac resynchronization therapy defibrillator (crt-d) screw, despite multiple attempts.The crt-d was removed and a replacement device was implanted.It was also reported that the right ventricular (rv) lead exhibited chest wall stimulation.Three days after the procedure, the rv lead was repositioned and remains in use.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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