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CARELINK PROGRAMMER Adverse Event — Malfunction (MDR 2182208-2020-00815)

CARELINK PROGRAMMER Adverse Event — Malfunction (MDR 2182208-2020-00815) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CARELINK PROGRAMMER; Generic name: PROGRAMMER, PACEMAKER; Manufacturer: MEDTRONIC, INC..

DeviceCARELINK PROGRAMMER
Generic namePROGRAMMER, PACEMAKER
ManufacturerMEDTRONIC, INC.
Report number2182208-2020-00815
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativePRODUCT ANALYSIS: AT ANALYSIS IT WAS DETERMINED THAT THE STYLUS PEN TIP WAS BROKEN AND NOT FUNCTIONAL AND THAT THE TOUCHSCREEN DISPLAY MALFUNCTIONED AT THE LOWER MIDDLE PART WHERE TWO LINES WOULD NOT RESPOND TO THE STYLUS PEN. IT WAS NOTED THAT THE PRINTER DRAWER WAS MISSING PARTS, THE KEYBOARD SPACE BAR WAS MISSING, THE RIGHT LOWER BULLET WAS MISSING, AND THE UPPER BULLETS WERE WORN. ALL FOUND DE
SourceopenFDA MAUDE (device adverse events)

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