← DeviceEvents
HomeDevice Adverse Events

HEARTMATE 3¿ Adverse Event — Injury (MDR 10004847)

HEARTMATE 3¿ Adverse Event — Injury (MDR 10004847) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE 3¿; Generic name: VENTRICULAR (ASSIST) BYPASS; Manufacturer: THORATEC CORPORATION.

DeviceHEARTMATE 3¿
Generic nameVENTRICULAR (ASSIST) BYPASS
ManufacturerTHORATEC CORPORATION
Report number10004847
Event typeInjury
Product problemN
Date received2020-04-28
NarrativeHEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) PRESENTS WITH EXTENSIVE MSSE DRIVELINE INFECTION REQUIRING SURGICAL INCISION AND DRAINAGE OF THE DRIVELINE TRACT WITH UNROOFING AND REPOSITIONING OF THE DRIVELINE, VACUUM DRESSING, IV ANTIBIOTICS, AND HIGHER STATUS UPGRADE FOR HEART TRANSPLANT.
SourceopenFDA MAUDE (device adverse events)

🔍 Search all device adverse events →