MAUDE report

MAUDE report 25439: CORDIS ACCUFIX BIPOLAR J-ATRIAL

Injury · received Aug 8, 1995 · TELECTRONICS PACING SYSTEMS, INC.

Key facts

MDR report key 25439
Report number 25439
Event type Injury
Brand name CORDIS ACCUFIX BIPOLAR J-ATRIAL
Catalog number 330-801
Manufacturer TELECTRONICS PACING SYSTEMS, INC.
Product code DTB
Device class Class III
Date received by FDA Aug 8, 1995
Report date Feb 23, 1995
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
  • 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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