K132924

Substantially Equivalent

MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)

Applicant: Medtronic, Inc.
Product code: DTE
Advisory panel: Cardiovascular
Date received: 2013-09-18
Decision date: 2013-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.