MAUDE report

MAUDE report 1555: UNKNOWN

Malfunction · received Oct 15, 1992 · MEDTRONIC

Key facts

MDR report key 1555
Report number 1555
Event type Malfunction
Brand name UNKNOWN
Model number 4012
Manufacturer MEDTRONIC
Product code DTB
Device class Class III
Date received by FDA Oct 15, 1992
Report date Sep 29, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1,000+ MAUDE reports for this brand
  • 100–999 Death reports for this brand
  • 1,000+ Injury reports for this brand
  • No Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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