MAUDE manufacturer profile

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) · NVY

MAUDE profile for Permanent Defibrillator Electrodes

Key facts

Manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer group ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Product code NVY
Product code name Permanent Defibrillator Electrodes

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Over-Sensing, No Known Impact Or Consequence To Patient, High impedance, Adverse Event Without Identified Device or Use Problem, Device Dislodged or Dislocated, Failure to Capture, Signal Artifact/Noise Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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