MAUDE report

MAUDE report 71025: SYNCHROMED

Other · received Feb 18, 1997 · MEDTRONIC, INC.

Key facts

MDR report key 71025
Report number 2182207-1997-00026
Event type Other
Brand name SYNCHROMED
Model number 8615S
Manufacturer MEDTRONIC, INC.
Product code LKK
Device class Class III
Date received by FDA Feb 18, 1997
Report date Jan 21, 1997
Report source Maude

At a glance

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