MAUDE report

MAUDE report 7850: TRIUMPH DR 3.2MM PULSE GENERATOR

Injury · received Apr 18, 1994 · MEDTRONIC, INC.

Key facts

MDR report key 7850
Report number 2124215-1994-00029
Event type Injury
Brand name TRIUMPH DR 3.2MM PULSE GENERATOR
Model number 1224
Manufacturer MEDTRONIC, INC.
Product code DXY
Device class Class III
Date received by FDA Apr 18, 1994
Report date Mar 30, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No 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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