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LEAD MODEL 304 Adverse Event — Malfunction (MDR 1644487-2020-00642)

LEAD MODEL 304 Adverse Event — Malfunction (MDR 1644487-2020-00642) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEAD MODEL 304; Generic name: LEAD; Manufacturer: LIVANOVA USA, INC..

DeviceLEAD MODEL 304
Generic nameLEAD
ManufacturerLIVANOVA USA, INC.
Report number1644487-2020-00642
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, HEALTH
NarrativePATIENT UNDERWENT FULL REVISION SURGERY. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.
SourceopenFDA MAUDE (device adverse events)

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