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
analyzer, pacemaker generator function
Product Code
DTC
Regulation Number
870.3630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOTRONIK, INC.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2017
34
34
2018
22
22
2019
139
139
2020
189
189
2021
637
637
2022
228
228
2023
237
237
2024
832
832
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
874
874
Computer Operating System Problem
777
777
Communication or Transmission Problem
607
607
Display or Visual Feedback Problem
568
568
Output Problem
149
149
Data Problem
117
117
Capturing Problem
115
115
Device Difficult to Program or Calibrate
112
112
Failure to Interrogate
107
107
Pacing Problem
85
85
Device Sensing Problem
74
74
Inadequate User Interface
46
46
Application Program Problem
23
23
Failure to Capture
20
20
Device Displays Incorrect Message
20
20
Power Problem
18
18
Impedance Problem
16
16
Signal Artifact/Noise
13
13
Over-Sensing
12
12
Inappropriate/Inadequate Shock/Stimulation
10
10
Unexpected Shutdown
10
10
Problem with Software Installation
8
8
Mechanical Problem
7
7
Under-Sensing
6
6
High impedance
5
5
Connection Problem
4
4
Loose or Intermittent Connection
4
4
Appropriate Term/Code Not Available
4
4
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Unable to Obtain Readings
3
3
Failure to Power Up
2
2
Application Program Version or Upgrade Problem
2
2
High Capture Threshold
2
2
Wireless Communication Problem
2
2
Battery Problem
2
2
Reset Problem
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Failure to Sense
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Corroded
1
1
Noise, Audible
1
1
Device Operational Issue
1
1
Image Display Error/Artifact
1
1
Program or Algorithm Execution Problem
1
1
Low impedance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1999
1999
No Known Impact Or Consequence To Patient
225
225
No Consequences Or Impact To Patient
76
76
Asystole
24
24
No Patient Involvement
15
15
Cardiac Arrest
9
9
Arrhythmia
6
6
Shock from Patient Lead(s)
6
6
Bradycardia
5
5
Tachycardia
5
5
Low Blood Pressure/ Hypotension
4
4
Insufficient Information
3
3
Dizziness
2
2
Shock
2
2
Undesired Nerve Stimulation
2
2
Loss of consciousness
2
2
Heart Block
2
2
Non specific EKG/ECG Changes
1
1
Syncope/Fainting
1
1
Pneumothorax
1
1
Atrial Fibrillation
1
1
Pericardial Effusion
1
1
Cardiac Tamponade
1
1
Pleural Effusion
1
1
Fall
1
1
-
-