MEDTRONIC EUROPE SARL SOLARA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
|
Back to Search Results |
|
Model Number W4TR06 |
Device Problem
Unable to Obtain Readings (1516)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/21/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated that the atrial rate histogram data was missing/invalid.Analysis of the device memory indicated the egm (electrogram) was not available.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) exhibited no electrograms (egm) during wireless scheduled transmission.However, during manual transmission the egm was always present.Subsequently, analysis of device data resulted in an out of specification finding.The device remains in use.No patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|
|
|