MAUDE report

MAUDE report 77158: LEAD EXTENSION ADAPTION VS.1

Injury · received Mar 15, 1997 · TELETRONICS PACING SYSTEMS

Key facts

MDR report key 77158
Report number 1316542-1997-00472
Event type Injury
Brand name LEAD EXTENSION ADAPTION VS.1
Model number 033-302
Catalog number U33302
Manufacturer TELETRONICS PACING SYSTEMS
Product code DTD
Device class Class II
Date received by FDA Mar 15, 1997
Report date Mar 14, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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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