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TPLC
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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
102
102
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
2447
2447
Mechanical Problem
969
969
No Display/Image
720
720
Calibration Problem
487
487
Display or Visual Feedback Problem
448
448
Output Problem
399
399
Break
348
348
Failure to Power Up
302
302
Device Displays Incorrect Message
244
244
No Device Output
237
237
Device Sensing Problem
234
234
Use of Device Problem
209
209
Nonstandard Device
204
204
Unexpected Shutdown
200
200
Component Missing
183
183
Electrical /Electronic Property Problem
174
174
Material Integrity Problem
157
157
Corroded
138
138
Contamination
102
102
Battery Problem
100
100
Power Problem
97
97
Failure to Capture
87
87
Loose or Intermittent Connection
83
83
Device Operates Differently Than Expected
63
63
Crack
61
61
Failure to Sense
51
51
Capturing Problem
49
49
Under-Sensing
41
41
Pacing Problem
36
36
Moisture Damage
35
35
Pacing Intermittently
33
33
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
Failure of Device to Self-Test
18
18
Device Contamination with Chemical or Other Material
17
17
Adverse Event Without Identified Device or Use Problem
17
17
Failure to Shut Off
16
16
Output below Specifications
16
16
Degraded
16
16
Over-Sensing
13
13
Difficult to Insert
13
13
Operating System Becomes Nonfunctional
13
13
Blocked Connection
13
13
Contamination /Decontamination Problem
12
12
Output above Specifications
11
11
Signal Artifact/Noise
10
10
No Pacing
9
9
Data Problem
9
9
Appropriate Term/Code Not Available
7
7
Failure to Calibrate
7
7
Loss of Power
6
6
Noise, Audible
6
6
Application Program Freezes, Becomes Nonfunctional
5
5
Defective Device
5
5
Impedance Problem
5
5
Computer Operating System Problem
5
5
Electronic Property Issue
5
5
Sensing Intermittently
5
5
Circuit Failure
5
5
Premature Discharge of Battery
4
4
Display Difficult to Read
4
4
Improper or Incorrect Procedure or Method
4
4
Defective Component
4
4
Detachment of Device or Device Component
4
4
Device Dislodged or Dislocated
3
3
Communication or Transmission Problem
3
3
Human-Device Interface Problem
3
3
Physical Resistance/Sticking
3
3
Device Inoperable
3
3
Misfire
3
3
Low Battery
3
3
Failure to Read Input Signal
3
3
Application Interface Becomes Non-Functional Or Program Exits Abnormally
3
3
Detachment Of Device Component
2
2
Material Discolored
2
2
Disconnection
2
2
Labelling, Instructions for Use or Training Problem
2
2
Device Emits Odor
2
2
Defibrillation/Stimulation Problem
2
2
Intermittent Loss of Power
2
2
Key or Button Unresponsive/not Working
2
2
Patient Device Interaction Problem
2
2
Inappropriate or Unexpected Reset
2
2
Material Protrusion/Extrusion
2
2
Mechanical Jam
2
2
Patient-Device Incompatibility
2
2
Deformation Due to Compressive Stress
2
2
Device Damaged by Another Device
2
2
Device Packaging Compromised
1
1
Electrical Power Problem
1
1
Device Operational Issue
1
1
Moisture or Humidity Problem
1
1
Compatibility Problem
1
1
Issue With Displayed Error Message
1
1
Material Distortion
1
1
Improper Device Output
1
1
Inadequate Lighting
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
3169
3169
No Clinical Signs, Symptoms or Conditions
2636
2636
No Known Impact Or Consequence To Patient
1095
1095
No Consequences Or Impact To Patient
103
103
Cardiac Arrest
69
69
Ventricular Fibrillation
36
36
Arrhythmia
28
28
Ventricular Tachycardia
20
20
Bradycardia
19
19
Tachycardia
18
18
Asystole
13
13
R On T Phenomenon
11
11
Loss of consciousness
11
11
Death
8
8
No Information
7
7
No Code Available
5
5
Complete Heart Block
5
5
Heart Block
4
4
Superficial (First Degree) Burn
3
3
Non specific EKG/ECG Changes
3
3
Low Blood Pressure/ Hypotension
3
3
Low Oxygen Saturation
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Injury
3
3
Chest Pain
3
3
Cardiopulmonary Arrest
3
3
Erythema
3
3
Pneumonia
2
2
Electro-Mechanical Dissociation
2
2
Burn, Thermal
2
2
Cardiogenic Shock
2
2
Loss Of Pulse
2
2
Hypoxia
2
2
Skin Inflammation/ Irritation
2
2
Sudden Cardiac Death
2
2
Pericardial Effusion
2
2
Syncope
2
2
Seizures
2
2
Shock
2
2
Abrasion
2
2
Mitral Regurgitation
1
1
Atrial Flutter
1
1
Septic Shock
1
1
Device Overstimulation of Tissue
1
1
Aspiration/Inhalation
1
1
Muscle Spasm(s)
1
1
Diminished Pulse Pressure
1
1
Respiratory Arrest
1
1
Drug Resistant Bacterial Infection
1
1
Cardiac Perforation
1
1
Skin Discoloration
1
1
Sepsis
1
1
Ventricular Flutter
1
1
Ectopic Heartbeat
1
1
Hemorrhage/Bleeding
1
1
Syncope/Fainting
1
1
Dyspnea
1
1
Torsades-de-Pointes
1
1
Unspecified Heart Problem
1
1
Renal Failure
1
1
Diaphoresis
1
1
Skin Tears
1
1
Respiratory Failure
1
1
Atrial Fibrillation
1
1
Blister
1
1
Dizziness
1
1
Muscle Stimulation
1
1
Blood Loss
1
1
Headache
1
1
Discomfort
1
1
Shaking/Tremors
1
1
Sweating
1
1
Insufficient Information
1
1
Perforation
1
1
Memory Loss/Impairment
1
1
Cardiac Tamponade
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
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