MAUDE report

MAUDE report 46235: PERMANENT PACING LEAD

Injury · received Oct 25, 1996 · OSCOR MEDICAL, CORP.

Key facts

MDR report key 46235
Report number 1035166-1996-90001
Event type Injury
Brand name PERMANENT PACING LEAD
Model number PY 52 BV
Manufacturer OSCOR MEDICAL, CORP.
Product code DTB
Device class Class III
Date received by FDA Oct 25, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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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