MAUDE manufacturer profile

ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) · OJX

MAUDE profile for Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Key facts

Manufacturer ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
Manufacturer group ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
Product code OJX
Product code name Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Device Dislodged or Dislocated, Failure to Capture, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Undesired Nerve Stimulation, No Clinical Signs, Symptoms or Conditions, Capturing Problem 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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