MAUDE report

MAUDE report 31639: ITREL II QUADRIPOLAR IMPLANTABLE PULSE GENERATOR

Injury · received Apr 1, 1996 · NEUROLOGICAL DIV. MEDTRONIC, INC.

Key facts

MDR report key 31639
Report number MW1008768
Event type Injury
Brand name ITREL II QUADRIPOLAR IMPLANTABLE PULSE GENERATOR
Model number 7424QT2108030H
Catalog number *
Manufacturer NEUROLOGICAL DIV. MEDTRONIC, INC.
Product code GZB
Device class Class II
Date received by FDA Apr 1, 1996
Report date Apr 1, 1996
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
  • 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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