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TPLC
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Device
recorder, event, implantable cardiac, (without arrhythmia detection)
Product Code
MXC
Regulation Number
870.2800
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT
SUBSTANTIALLY EQUIVALENT
2
1. K190295
Confirm Rx Insertable Cardiac Monitor
2. K193310
myMerlin Mobile Application (Android), myMerlin Mo
...
3. K202876
Confirm Rx Insertable Cardiac Monitor
4. K202888
Confirm Rx Insertable Cardiac Monitor
5. K212206
Jot Dx Insertable Cardiac Monitor
ABBOTT (ST. JUDE MEDICAL)
SUBSTANTIALLY EQUIVALENT
5
1. K190295
Confirm Rx Insertable Cardiac Monitor
2. K193310
myMerlin Mobile Application (Android), myMerlin Mo
...
3. K202876
Confirm Rx Insertable Cardiac Monitor
4. K202888
Confirm Rx Insertable Cardiac Monitor
5. K212206
Jot Dx Insertable Cardiac Monitor
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL
SUBSTANTIALLY EQUIVALENT
3
1. K190295
Confirm Rx Insertable Cardiac Monitor
2. K193310
myMerlin Mobile Application (Android), myMerlin Mo
...
3. K202876
Confirm Rx Insertable Cardiac Monitor
4. K202888
Confirm Rx Insertable Cardiac Monitor
5. K212206
Jot Dx Insertable Cardiac Monitor
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
TRANSOMA
SUBSTANTIALLY EQUIVALENT
1
TRANSOMA MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
598
598
2015
235
235
2016
194
194
2017
226
226
2018
1819
1819
2019
1593
1593
2020
1100
1100
2021
832
832
2022
628
628
2023
828
828
2024
226
226
Device Problems
MDRs with this Device Problem
Events in those MDRs
Under-Sensing
3774
3774
Over-Sensing
989
989
Failure to Interrogate
791
791
Adverse Event Without Identified Device or Use Problem
431
431
Data Problem
421
421
Signal Artifact/Noise
335
335
Premature Discharge of Battery
293
293
Pacemaker Found in Back-Up Mode
255
255
Failure to Sense
228
228
Device Displays Incorrect Message
218
218
Incorrect Measurement
214
214
Device Operates Differently Than Expected
155
155
Device Sensing Problem
152
152
Inappropriate or Unexpected Reset
129
129
Sensing Intermittently
118
118
Incorrect, Inadequate or Imprecise Result or Readings
114
114
Incorrect Interpretation of Signal
106
106
Wireless Communication Problem
104
104
Communication or Transmission Problem
99
99
Migration or Expulsion of Device
95
95
Interrogation Problem
82
82
Difficult to Interrogate
52
52
Detachment of Device or Device Component
51
51
Telemetry Discrepancy
42
42
Migration
39
39
Appropriate Term/Code Not Available
33
33
Break
26
26
Decreased Sensitivity
24
24
Use of Device Problem
23
23
Premature Elective Replacement Indicator
23
23
Battery Problem
22
22
Low Sensing Threshold
17
17
Application Program Version or Upgrade Problem
15
15
No Apparent Adverse Event
15
15
Insufficient Information
15
15
Computer Software Problem
11
11
Electromagnetic Interference
10
10
Out-Of-Box Failure
8
8
Failure to Capture
7
7
Reset Problem
7
7
Failure to Transmit Record
6
6
Improper or Incorrect Procedure or Method
5
5
Defective Device
5
5
Connection Problem
5
5
Loss of Data
5
5
Problem with Software Installation
5
5
Programming Issue
5
5
Device Dislodged or Dislocated
5
5
Intermittent Communication Failure
5
5
Image Display Error/Artifact
4
4
Use of Incorrect Control/Treatment Settings
3
3
Device Difficult to Program or Calibrate
3
3
Computer Operating System Problem
3
3
Cut In Material
3
3
Dull, Blunt
2
2
Invalid Sensing
2
2
Material Separation
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Device-Device Incompatibility
2
2
Patient-Device Incompatibility
2
2
Application Program Problem
2
2
Failure to Disconnect
2
2
Product Quality Problem
2
2
Detachment Of Device Component
2
2
Loose or Intermittent Connection
2
2
Unintended Movement
2
2
Operating System Version or Upgrade Problem
2
2
Issue With Displayed Error Message
2
2
Manufacturing, Packaging or Shipping Problem
1
1
Temperature Problem
1
1
Positioning Problem
1
1
Power Problem
1
1
Compatibility Problem
1
1
Installation-Related Problem
1
1
Missing Test Results
1
1
No Pacing
1
1
Excessive Heating
1
1
Missing Information
1
1
False Device Output
1
1
Fracture
1
1
Material Fragmentation
1
1
Crack
1
1
Display or Visual Feedback Problem
1
1
Therapy Delivered to Incorrect Body Area
1
1
Unable to Obtain Readings
1
1
Misconnection
1
1
Nonstandard Device
1
1
No Device Output
1
1
Overheating of Device
1
1
Difficult to Remove
1
1
Pocket Stimulation
1
1
Failure to Analyze Signal
1
1
Year 2000 (Y2K) related problem
1
1
Low Battery
1
1
Computer System Security Problem
1
1
Calibration Problem
1
1
Failure to Read Input Signal
1
1
Shelf Life Exceeded
1
1
Electro-Static Discharge
1
1
Device Damaged Prior to Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
4984
4984
No Clinical Signs, Symptoms or Conditions
2312
2312
No Consequences Or Impact To Patient
317
317
Unspecified Infection
153
153
Pocket Erosion
142
142
No Patient Involvement
82
82
Discomfort
81
81
Erosion
80
80
Insufficient Information
61
61
Wound Dehiscence
42
42
No Information
32
32
Syncope
27
27
Pain
26
26
Death
15
15
Hematoma
13
13
Twiddlers Syndrome
12
12
Complaint, Ill-Defined
11
11
Dizziness
11
11
Cardiac Arrest
11
11
Bradycardia
9
9
Arrhythmia
7
7
Hypersensitivity/Allergic reaction
5
5
No Code Available
5
5
Palpitations
4
4
Hemorrhage/Bleeding
4
4
Atrial Fibrillation
4
4
Dyspnea
4
4
Fainting
3
3
Fever
3
3
Chest Pain
3
3
Anxiety
3
3
Burning Sensation
3
3
Tachycardia
2
2
Therapeutic Effects, Unexpected
2
2
Impaired Healing
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Scar Tissue
2
2
Erythema
2
2
Fall
1
1
Stroke/CVA
1
1
Purulent Discharge
1
1
Abrasion
1
1
Abscess
1
1
Achalasia
1
1
Seizures
1
1
Shock
1
1
Swelling
1
1
Rash
1
1
Foreign Body Reaction
1
1
Headache
1
1
Hemostasis
1
1
Irritation
1
1
Itching Sensation
1
1
Nausea
1
1
Syncope/Fainting
1
1
Skin Tears
1
1
Blood Loss
1
1
Complete Heart Block
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Shock from Patient Lead(s)
1
1
Device Embedded In Tissue or Plaque
1
1
Reaction
1
1
Collapse
1
1
Post Operative Wound Infection
1
1
Distress
1
1
Injury
1
1
Blurred Vision
1
1
Excessive Tear Production
1
1
Urticaria
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott
II
Apr-25-2019
2
St Jude Medical CRMD
II
Jul-05-2011
3
St Jude Medical Inc.
II
Jun-29-2018
4
St Jude Medical, Cardiac Rhythm Management Division
II
Jan-13-2020
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