MAUDE report

MAUDE report 948: PACEMAKER, A-V

Injury · received Jul 20, 1992 · SIEMENS PACESETTER, INC.

Key facts

MDR report key 948
Report number 948
Event type Injury
Brand name PACEMAKER, A-V
Model number AFP
Manufacturer SIEMENS PACESETTER, INC.
Product code DXY
Device class Class III
Date received by FDA Jul 20, 1992
Report date Jul 10, 1992
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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