MEDTRONIC EUROPE SARL SERENA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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Model Number W1TR05 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: 1156t ,lead, implanted: unknown.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during the replacement procedure, the physician could not hear the clicking sound after connecting the lead to the cardiac resynchronization therapy pacemaker (crt-p).It was noted that the physician rotated the screwdriver many times and used another screwdriver, but no sound was heard.The lead measurements were good, and the fluoroscopy images showed the lead fit well in the connection port.The device remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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