MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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Model Number 6935M55 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 09/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: 407652 lead, implanted: (b)(6) 2017.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 by the patient representative that the patient's lead is 'messed up' and 'bad,' and that it 'jiggles' and blood is pooling in their heart.The lead 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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