MAUDE manufacturer profile

MDT PUERTO RICO OPERATIONS CO · LKK

MAUDE profile for Pump, Infusion, Implanted, Programmable

Key facts

Manufacturer MDT PUERTO RICO OPERATIONS CO
Manufacturer group MEDTRONIC NEUROMODULATION
Product code LKK
Product code name Pump, Infusion, Implanted, Programmable

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Therapeutic Response, Decreased, Adverse Event Without Identified Device or Use Problem, Pain, Pumping Stopped, Device Operates Differently Than Expected, Device Displays Incorrect Message, Complaint, Ill-Defined 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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