Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
pulse-generator, pacemaker, external
Product Code
DTE
Regulation Number
870.3600
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
7
OSYPKA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
67
67
2015
342
342
2016
496
496
2017
654
654
2018
956
956
2019
1001
1001
2020
1092
1092
2021
899
899
2022
833
833
2023
650
650
2024
420
420
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
2484
2484
Mechanical Problem
1013
1013
No Display/Image
762
762
Calibration Problem
522
522
Display or Visual Feedback Problem
469
469
Output Problem
434
434
Break
360
360
Failure to Power Up
306
306
Device Sensing Problem
276
276
No Device Output
261
261
Device Displays Incorrect Message
244
244
Use of Device Problem
223
223
Unexpected Shutdown
218
218
Nonstandard Device
204
204
Electrical /Electronic Property Problem
186
186
Component Missing
186
186
Material Integrity Problem
172
172
Corroded
138
138
Battery Problem
105
105
Contamination
102
102
Power Problem
98
98
Failure to Capture
90
90
Loose or Intermittent Connection
85
85
Crack
64
64
Device Operates Differently Than Expected
63
63
Capturing Problem
54
54
Failure to Sense
52
52
Under-Sensing
44
44
Pacing Problem
37
37
Pacing Intermittently
36
36
Moisture Damage
35
35
Insufficient Information
33
33
Computer Software Problem
31
31
Inadequate User Interface
25
25
Device Difficult to Program or Calibrate
23
23
Intermittent Capture
20
20
Adverse Event Without Identified Device or Use Problem
18
18
Failure of Device to Self-Test
18
18
Device Contamination with Chemical or Other Material
17
17
Degraded
16
16
Failure to Shut Off
16
16
Output below Specifications
16
16
Over-Sensing
15
15
Operating System Becomes Nonfunctional
14
14
Blocked Connection
13
13
Difficult to Insert
13
13
Contamination /Decontamination Problem
13
13
Output above Specifications
12
12
Signal Artifact/Noise
10
10
Data Problem
9
9
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
3169
3169
No Clinical Signs, Symptoms or Conditions
2937
2937
No Known Impact Or Consequence To Patient
1095
1095
No Consequences Or Impact To Patient
103
103
Cardiac Arrest
74
74
Ventricular Fibrillation
39
39
Arrhythmia
30
30
Tachycardia
23
23
Bradycardia
21
21
Ventricular Tachycardia
20
20
Asystole
16
16
R On T Phenomenon
11
11
Loss of consciousness
11
11
Death
8
8
No Information
7
7
No Code Available
5
5
Heart Block
5
5
Complete Heart Block
5
5
Superficial (First Degree) Burn
4
4
Low Blood Pressure/ Hypotension
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Cardiopulmonary Arrest
3
3
Insufficient Information
3
3
Low Oxygen Saturation
3
3
Erythema
3
3
Non specific EKG/ECG Changes
3
3
Chest Pain
3
3
Injury
3
3
Pneumonia
2
2
Shock
2
2
Cardiogenic Shock
2
2
Syncope
2
2
Sudden Cardiac Death
2
2
Loss Of Pulse
2
2
Hypoxia
2
2
Electro-Mechanical Dissociation
2
2
Seizures
2
2
Pericardial Effusion
2
2
Blister
2
2
Abrasion
2
2
Burn, Thermal
2
2
Skin Inflammation/ Irritation
2
2
Diaphoresis
2
2
Ectopic Heartbeat
1
1
Skin Tears
1
1
Unspecified Heart Problem
1
1
Shaking/Tremors
1
1
Mitral Regurgitation
1
1
Ventricular Flutter
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bio-Detek, Inc.
II
Jul-03-2019
2
Medtronic Inc. Cardiac Rhythm Disease Management
II
Mar-31-2015
3
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jun-29-2018
4
Osypka Medical Inc
II
Sep-21-2010
-
-