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MERLIN@HOME, RF TELEMETRY BASIC Adverse Event — Malfunction (MDR 2017865-2020-05468)

MERLIN@HOME, RF TELEMETRY BASIC Adverse Event — Malfunction (MDR 2017865-2020-05468) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MERLIN@HOME, RF TELEMETRY BASIC; Generic name: PACEMAKER DATA TRANSMITTER; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).

DeviceMERLIN@HOME, RF TELEMETRY BASIC
Generic namePACEMAKER DATA TRANSMITTER
ManufacturerST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Report number2017865-2020-05468
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE, CONSUM
NarrativeTHE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
SourceopenFDA MAUDE (device adverse events)

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