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TILDA R 53 US Adverse Event — Malfunction (MDR 1028232-2020-01865)

TILDA R 53 US Adverse Event — Malfunction (MDR 1028232-2020-01865) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TILDA R 53 US; Generic name: LEAD; Manufacturer: BIOTRONIK SE & CO. KG.

DeviceTILDA R 53 US
Generic nameLEAD
ManufacturerBIOTRONIK SE & CO. KG
Report number1028232-2020-01865
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE
NarrativeIT WAS REPORTED IN REGARD TO THIS RV LEAD THAT: THIS LEAD WAS FRACTURED DUE TO SUBCLAVIAN CRUSH. THE LEAD WAS EXPLANTED.
SourceopenFDA MAUDE (device adverse events)

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