Cardiovascular · 510(k) · 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Medtronic, Inc.. Cleared by FDA on 26 April 2023 under submission K230553, product code MXD (recorder, event, implantable cardiac, (with arrhythmia detection)). What FDA's record says, in FDA's words.
Device record · K230553
- Device. LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationDEVICE
- Company. Medtronic, Inc.COMPANY
- Decision. 26 April 2023, 510(k), substantially equivalent (traditional review); received 28 February 2023DECISION
- Panel. CardiovascularPANEL
- Product code. MXD, Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)CODE
- Regulation. 21 CFR 870.1025, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases: • patients with clinical syndromes or situations at increased risk of cardiac arrhythmias • patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 13,169 reports filed against devices carrying product code MXD. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07287
It was reported that the Implantable Cardiac Monitor (ICM) detected fast tachycardia episodes (FVT) due to noise. The ICM remains in use. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07288
It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing Premature Ventricular Contractions (PVC)'s. It was further reported that the remote monitoring report displayed ?? marks under Current Counters and Reason For Monitoring. The ICM remains in use. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07290
It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing. It was further reported that the Remote Monitoring Report displayed ?? marks under Current Counters. The ICM remains in use. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07291
It was reported that the Implantable Cardiac Monitor (ICM) displayed early Recommended Replacement Time (RRT) having been implanted approximately 29 months. It was noted that the ICM did not meet the minimum expected longevity when accounting for device usage. The ICM remains in the patient. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07292
It was reported that the Implantable Cardiac Monitor (ICM) displayed early Recommended Replacement Time (RRT) having been implanted approximately 27 months. It was noted that the ICM did not meet the minimum expected longevity when accounting for device usage. The ICM remains in the patient. No patient complications have been reported as a result of this event.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MXD, in Cardiovascular, from Medtronic, Inc., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.