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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
4
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
955
955
2019
1001
1001
2020
1092
1092
2021
899
899
2022
834
834
2023
111
111
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
1737
1737
Mechanical Problem
715
715
No Display/Image
517
517
Display or Visual Feedback Problem
395
395
Calibration Problem
385
385
Break
269
269
Output Problem
244
244
Failure to Power Up
217
217
Use of Device Problem
191
191
Unexpected Shutdown
164
164
Device Sensing Problem
147
147
No Device Output
132
132
Component Missing
125
125
Material Integrity Problem
123
123
Electrical /Electronic Property Problem
119
119
Corroded
100
100
Battery Problem
79
79
Failure to Capture
63
63
Loose or Intermittent Connection
62
62
Device Displays Incorrect Message
61
61
Contamination
59
59
Power Problem
51
51
Crack
37
37
Capturing Problem
33
33
Failure to Sense
30
30
Insufficient Information
30
30
Nonstandard Device
25
25
Moisture Damage
24
24
Pacing Problem
24
24
Pacing Intermittently
24
24
Under-Sensing
20
20
Inadequate User Interface
20
20
Intermittent Capture
18
18
Computer Software Problem
16
16
Adverse Event Without Identified Device or Use Problem
15
15
Device Difficult to Program or Calibrate
14
14
Output below Specifications
13
13
Device Operates Differently Than Expected
12
12
Contamination /Decontamination Problem
11
11
Blocked Connection
11
11
Difficult to Insert
10
10
Failure to Shut Off
10
10
Output above Specifications
9
9
Signal Artifact/Noise
8
8
Over-Sensing
7
7
Data Problem
7
7
Operating System Becomes Nonfunctional
7
7
No Pacing
6
6
Failure to Calibrate
6
6
Defective Device
5
5
Circuit Failure
5
5
Degraded
5
5
Noise, Audible
5
5
Device Contamination with Chemical or Other Material
5
5
Failure of Device to Self-Test
4
4
Appropriate Term/Code Not Available
4
4
Application Program Freezes, Becomes Nonfunctional
4
4
Detachment of Device or Device Component
4
4
Defective Component
3
3
Misfire
3
3
Sensing Intermittently
3
3
Failure to Read Input Signal
3
3
Display Difficult to Read
3
3
Physical Resistance/Sticking
3
3
Electronic Property Issue
3
3
Inappropriate or Unexpected Reset
2
2
Impedance Problem
2
2
Mechanical Jam
2
2
Intermittent Loss of Power
2
2
Key or Button Unresponsive/not Working
2
2
Patient Device Interaction Problem
2
2
Material Discolored
2
2
Device Emits Odor
2
2
Improper or Incorrect Procedure or Method
2
2
Deformation Due to Compressive Stress
2
2
Patient-Device Incompatibility
2
2
Communication or Transmission Problem
2
2
Computer Operating System Problem
1
1
Sparking
1
1
Inappropriate Waveform
1
1
Material Perforation
1
1
Incomplete or Missing Packaging
1
1
Cut In Material
1
1
Structural Problem
1
1
Failure to Align
1
1
Sticking
1
1
Product Quality Problem
1
1
Material Separation
1
1
Defibrillation/Stimulation Problem
1
1
Energy Output Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Leak/Splash
1
1
Fracture
1
1
Loss of Power
1
1
Device Difficult to Setup or Prepare
1
1
Disconnection
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Electromagnetic Interference
1
1
Arcing at Paddles
1
1
Premature Discharge of Battery
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2168
2168
No Clinical Signs, Symptoms or Conditions
2021
2021
No Known Impact Or Consequence To Patient
600
600
No Consequences Or Impact To Patient
100
100
Cardiac Arrest
46
46
Arrhythmia
24
24
Ventricular Fibrillation
20
20
Tachycardia
14
14
Bradycardia
11
11
Loss of consciousness
7
7
Ventricular Tachycardia
7
7
Asystole
7
7
No Code Available
5
5
R On T Phenomenon
4
4
No Information
4
4
Heart Block
4
4
Death
4
4
Non specific EKG/ECG Changes
3
3
Low Blood Pressure/ Hypotension
3
3
Erythema
3
3
Injury
3
3
Skin Inflammation/ Irritation
2
2
Burn, Thermal
2
2
Pneumonia
2
2
Hypoxia
2
2
Cardiopulmonary Arrest
2
2
Syncope
2
2
Abrasion
2
2
Aspiration/Inhalation
1
1
Chest Pain
1
1
Muscle Stimulation
1
1
Memory Loss/Impairment
1
1
Muscle Spasm(s)
1
1
Perforation
1
1
Electro-Mechanical Dissociation
1
1
Dyspnea
1
1
Sepsis
1
1
Septic Shock
1
1
Skin Discoloration
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Torsades-de-Pointes
1
1
Sweating
1
1
Diaphoresis
1
1
Low Oxygen Saturation
1
1
Respiratory Failure
1
1
Sudden Cardiac Death
1
1
Shaking/Tremors
1
1
Skin Tears
1
1
Loss Of Pulse
1
1
Complete Heart Block
1
1
Superficial (First Degree) Burn
1
1
Discomfort
1
1
Unspecified Heart Problem
1
1
Blister
1
1
Ectopic Heartbeat
1
1
Pericardial Effusion
1
1
Syncope/Fainting
1
1
Drug Resistant Bacterial Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bio-Detek, Inc.
II
Jul-03-2019
2
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jun-29-2018
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