FDAJune 21, 2018device
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequent...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
What to do
FDA enforcement status: Terminated
Brands named
medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc
UPCs
00643169735705
Recall history
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