MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)— 510(k) K132924

Name: FDA 510(k) clearance K132924
Creator: U.S. Food and Drug Administration
Published: 2013-10-31

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K132924 for MEDTRONIC EXTERNAL PULSE GENERATOR (EPG), Substantially Equivalent on 2013-10-31. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 2013-09-18
Decision date: 2013-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTE

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K241781 — Solo Pace Control2025-01-10
K232721 — Lifetech Cardio Temporary Pacemaker2024-01-07
K201011 — Medtronic Model 5392 External Pulse Generator (EPG)2020-05-13
K190825 — Medtronic Model 5392 External Pulse Generator (EPG)2019-04-30
K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker2019-02-28

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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 →

Recalls naming K132924

K-number listed on FDA's recall record

Z-1356-2015 — Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary cardiac pacing include, but are not limited to, the following: - Complete heart block - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient before permanent pacemaker implantation - Support during permanent pacemaker replacement - Cardiac complications during invasive or surgical procedures - Support following cardiac surgery - Acute myocardial infarction complicated by heart block - Atrial tachyarrhythmias that require high-rate burst pacing for treatmentClass II·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·20150317

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132924.

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