MAUDE report

MAUDE report 75806: MEDTRONIC PACEMAKER

Injury · received Mar 10, 1997 · MEDTRONIC, INC

Key facts

MDR report key 75806
Report number 75806.3
Event type Injury
Brand name MEDTRONIC PACEMAKER
Model number 8940
Catalog number *
Manufacturer MEDTRONIC, INC
Product code DXY
Device class Class III
Date received by FDA Mar 10, 1997
Report date Dec 17, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 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:

Browse all MAUDE medical device reports