510(k) K140972— UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING

Substantially Equivalent

Medtronic, Inc.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 2014-04-16
Decision date: 2014-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Ana, CA, US

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.