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
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
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
4
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
654
654
2018
955
955
2019
1001
1001
2020
1092
1092
2021
899
899
2022
275
275
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
1950
1950
Mechanical Problem
683
683
No Display/Image
443
443
Calibration Problem
341
341
Display or Visual Feedback Problem
321
321
Break
263
263
Output Problem
230
230
Failure to Power Up
184
184
Use of Device Problem
152
152
Component Missing
139
139
Unexpected Shutdown
126
126
No Device Output
125
125
Device Sensing Problem
122
122
Electrical /Electronic Property Problem
117
117
Device Displays Incorrect Message
113
113
Material Integrity Problem
106
106
Battery Problem
73
73
Corroded
63
63
Power Problem
63
63
Loose or Intermittent Connection
58
58
Failure to Capture
56
56
Contamination
48
48
Crack
34
34
Failure to Sense
32
32
Insufficient Information
30
30
Under-Sensing
28
28
Device Operates Differently Than Expected
27
27
Nonstandard Device
25
25
Pacing Intermittently
24
24
Moisture Damage
23
23
Capturing Problem
23
23
Pacing Problem
21
21
Device Difficult to Program or Calibrate
19
19
Intermittent Capture
18
18
Inadequate User Interface
18
18
Computer Software Problem
17
17
Degraded
13
13
Output below Specifications
12
12
Failure to Shut Off
11
11
Difficult to Insert
11
11
Blocked Connection
11
11
Contamination /Decontamination Problem
10
10
Output above Specifications
10
10
Operating System Becomes Nonfunctional
10
10
Data Problem
8
8
Device Contamination with Chemical or Other Material
8
8
No Pacing
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Signal Artifact/Noise
7
7
Over-Sensing
6
6
Noise, Audible
6
6
Appropriate Term/Code Not Available
5
5
Electronic Property Issue
5
5
Defective Device
5
5
Failure to Calibrate
5
5
Sensing Intermittently
4
4
Detachment of Device or Device Component
4
4
Failure of Device to Self-Test
3
3
Impedance Problem
3
3
Physical Resistance/Sticking
3
3
Application Program Freezes, Becomes Nonfunctional
3
3
Failure to Read Input Signal
3
3
Defective Component
3
3
Misfire
3
3
Display Difficult to Read
3
3
Premature Discharge of Battery
2
2
Circuit Failure
2
2
Device Emits Odor
2
2
Patient-Device Incompatibility
2
2
Deformation Due to Compressive Stress
2
2
Communication or Transmission Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Intermittent Loss of Power
2
2
Patient Device Interaction Problem
2
2
Mechanical Jam
2
2
Inappropriate or Unexpected Reset
2
2
Device Dislodged or Dislocated
2
2
Electrical Power Problem
1
1
Device Operational Issue
1
1
Material Protrusion/Extrusion
1
1
Inadequate Lighting
1
1
Operating System Version or Upgrade Problem
1
1
Scratched Material
1
1
Component Misassembled
1
1
Device Handling Problem
1
1
Incomplete or Inadequate Connection
1
1
Key or Button Unresponsive/not Working
1
1
Material Perforation
1
1
Device Inoperable
1
1
Cut In Material
1
1
Structural Problem
1
1
Failure to Align
1
1
Device Slipped
1
1
Sticking
1
1
Material Separation
1
1
Product Quality Problem
1
1
Computer Operating System Problem
1
1
Increased Sensitivity
1
1
Inappropriate Waveform
1
1
Low Battery
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2620
2620
No Clinical Signs, Symptoms or Conditions
1381
1381
No Known Impact Or Consequence To Patient
771
771
No Consequences Or Impact To Patient
102
102
Cardiac Arrest
43
43
Ventricular Fibrillation
23
23
Ventricular Tachycardia
15
15
Arrhythmia
15
15
Bradycardia
14
14
R On T Phenomenon
9
9
Tachycardia
8
8
Loss of consciousness
6
6
Death
6
6
No Information
5
5
No Code Available
5
5
Asystole
3
3
Heart Block
3
3
Cardiopulmonary Arrest
3
3
Erythema
3
3
Injury
3
3
Sudden Cardiac Death
2
2
Burn, Thermal
2
2
Non specific EKG/ECG Changes
2
2
Low Blood Pressure/ Hypotension
2
2
Syncope
2
2
Abrasion
2
2
Complete Heart Block
2
2
Skin Inflammation/ Irritation
2
2
Unspecified Heart Problem
1
1
Blister
1
1
Ectopic Heartbeat
1
1
Syncope/Fainting
1
1
Chest Pain
1
1
Dyspnea
1
1
Hypoxia
1
1
Memory Loss/Impairment
1
1
Muscle Spasm(s)
1
1
Skin Discoloration
1
1
Electro-Mechanical Dissociation
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Loss Of Pulse
1
1
Diminished Pulse Pressure
1
1
Shaking/Tremors
1
1
Skin Tears
1
1
Sweating
1
1
Diaphoresis
1
1
Low Oxygen Saturation
1
1
Muscle Stimulation
1
1
Cardiogenic Shock
1
1
Discomfort
1
1
Torsades-de-Pointes
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
-
-