MAUDE manufacturer profile

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

MAUDE profile for Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Key facts

Manufacturer ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
Manufacturer group ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
Product code MHY
Product code name Stimulator, Electrical, Implanted, For Parkinsonian Tremor

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Failure of Implant, Battery Problem, Adverse Event Without Identified Device or Use Problem, Movement Disorder, No Clinical Signs, Symptoms or Conditions, Post Operative Wound Infection, Wireless Communication Problem, Unspecified Infection 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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