inforMED
NVNClass IIIImplantLife-sustaining

Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes

Unknown

Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.

MDR events228,094All time
Recalls0All time
Registered firms64Currently listed
510(k) clearances0All time

Recent MDR events

228,094 adverse event reports on file

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Event type breakdown

Injury128,126
Malfunction94,775
Death5,055
Unspecified99
Other39

Most-reported manufacturers

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St. Jude Medical, Inc.(crm-sylmar)66,520Boston Scientific Corporation36,525Mpri28,483Biotronik Se & Co. Kg26,435Cpi - Del Caribe12,034St. Jude Medical, Inc.(crm-sunnyvale)9,582St. Jude Medical, Inc., Crmd8,145Abbott7,032

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

64 firms currently registered for this product code

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510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.

PMA approvals

12 premarket approvals for this product code

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