MAUDE report

MAUDE report 9625: PACEMAKER SENSING LEAD

No Answer Provided · received Aug 2, 1993 · MEDTRONIC INC.

Key facts

MDR report key 9625
Report number 9625
Event type No Answer Provided
Brand name PACEMAKER SENSING LEAD
Model number LEAD NUMBER 4016
Manufacturer MEDTRONIC INC.
Product code DTB
Device class Class III
Date received by FDA Aug 2, 1993
Report date Aug 2, 1993
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
  • None Injury reports for this brand
  • 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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