MAUDE report

MAUDE report 28619: MEDTRONIC LEAD AND GENERATOR

Injury · received Nov 7, 1995 · MEDTRONIC, INC.

Key facts

MDR report key 28619
Report number 28619
Event type Injury
Brand name MEDTRONIC LEAD AND GENERATOR
Model number 6966
Manufacturer MEDTRONIC, INC.
Product code LWS
Device class Class III
Date received by FDA Nov 7, 1995
Report date Oct 20, 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:

Browse all MAUDE medical device reports