MAUDE manufacturer profile

ABBOTT · NVZ

MAUDE profile for Pulse Generator, Permanent, Implantable

Key facts

Manufacturer ABBOTT
Manufacturer group ABBOTT
Product code NVZ
Product code name Pulse Generator, Permanent, Implantable

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
  • No Clinical Signs, Symptoms or Conditions, Failure to Interrogate, Adverse Event Without Identified Device or Use Problem, Premature Discharge of Battery, No Known Impact Or Consequence To Patient, No Pacing, Pacemaker Found in Back-Up Mode, Incorrect Measurement 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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