MAUDE report

MAUDE report 11113: SYNCHRONY II

No Answer Provided · received Jan 26, 1994 · PACESETTERS SYSTEMS DIV. SIEMANS PACESETTER, INC.

Key facts

MDR report key 11113
Report number MW4000072
Event type No Answer Provided
Brand name SYNCHRONY II
Model number 2022T
Manufacturer PACESETTERS SYSTEMS DIV. SIEMANS PACESETTER, INC.
Product code DXY
Device class Class III
Date received by FDA Jan 26, 1994
Report date Jul 15, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 100–999 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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