MAUDE manufacturer profile

MDT SOFAMOR DANEK PUERTO RICO MFG · LGW

MAUDE profile for Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Key facts

Manufacturer MDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer group MDT SOFAMOR DANEK PUERTO RICO MFG
Product code LGW
Product code name Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Device Operates Differently Than Expected, No Known Impact Or Consequence To Patient, Therapeutic Effects, Unexpected, Adverse Event Without Identified Device or Use Problem, Pain, Insufficient Information, Failure to Deliver Energy, 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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