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Device
programmer, pacemaker
Regulation Description
Pacemaker programmers.
Product Code
KRG
Regulation Number
870.3700
Device Class
3
MDR Year
MDR Reports
MDR Events
2016
1886
1886
2017
1407
1407
2018
1326
1326
2019
1175
1175
2020
1683
1683
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Difficult to Program or Calibrate
1427
1427
No Display/Image
1016
1016
Computer Operating System Problem
787
787
Output Problem
709
709
Failure to Calibrate
621
621
Computer Software Problem
521
521
Device Operates Differently Than Expected
458
458
Communication or Transmission Problem
422
422
Electrical /Electronic Property Problem
345
345
Power Problem
324
324
Inadequate User Interface
316
316
Unexpected Shutdown
302
302
Mechanical Problem
269
269
Overheating of Device
264
264
Failure to Power Up
226
226
Connection Problem
226
226
Problem with Software Installation
214
214
Data Problem
166
166
Display or Visual Feedback Problem
160
160
Failure to Interrogate
145
145
Incorrect Measurement
142
142
Noise, Audible
134
134
Material Integrity Problem
133
133
Break
128
128
Signal Artifact/Noise
124
124
Use of Device Problem
121
121
Loose or Intermittent Connection
99
99
Operating System Becomes Nonfunctional
95
95
Device Sensing Problem
79
79
Adverse Event Without Identified Device or Use Problem
74
74
Crack
64
64
Calibration Problem
63
63
Application Interface Becomes Non-Functional Or Program Exits Abnormally
55
55
Device Displays Incorrect Message
52
52
High impedance
51
51
Over-Sensing
50
50
Corroded
48
48
Battery Problem
48
48
Interrogation Problem
45
45
Ambient Noise Problem
41
41
Device Emits Odor
36
36
Contamination
35
35
Application Program Freezes, Becomes Nonfunctional
33
33
No Device Output
33
33
Degraded
29
29
Improper Device Output
29
29
Inappropriate/Inadequate Shock/Stimulation
28
28
Impedance Problem
27
27
Insufficient Information
27
27
Failure to Sense
26
26
Thermal Decomposition of Device
26
26
Electrical Shorting
25
25
Capturing Problem
20
20
Component Missing
18
18
Appropriate Term/Code Not Available
18
18
Failure to Capture
16
16
Device Contamination with Chemical or Other Material
15
15
Under-Sensing
13
13
Loss of Power
12
12
Low impedance
12
12
Premature Discharge of Battery
12
12
Erratic or Intermittent Display
11
11
Pacing Problem
11
11
Failure to Shut Off
11
11
Device Operational Issue
10
10
Application Program Problem
10
10
Incorrect Software Programming Calculations
10
10
Incorrect, Inadequate or Imprecise Resultor Readings
9
9
Contamination /Decontamination Problem
9
9
Issue With Displayed Error Message
8
8
Cut In Material
8
8
Sparking
8
8
Wireless Communication Problem
7
7
Screen
7
7
Device Alarm System
6
6
Device Programmer
6
6
Display Difficult to Read
6
6
Incorrect Or Inadequate Test Results
6
6
Structural Problem
6
6
Smoking
6
6
Telemetry Discrepancy
6
6
Application Program Version or Upgrade Problem
6
6
No Audible Alarm
6
6
Electromagnetic Interference
6
6
Blocked Connection
5
5
Date/Time-Related Software Problem
5
5
Defective Device
5
5
Material Perforation
5
5
Electrical Power Problem
5
5
No Pacing
5
5
Intermittent Communication Failure
4
4
Defibrillation/Stimulation Problem
4
4
Output above Specifications
4
4
Imprecision
4
4
Moisture Damage
4
4
Failure to Align
4
4
Operating System Version or Upgrade Problem
4
4
Material Twisted/Bent
4
4
Bent
4
4
Therapeutic or Diagnostic Output Failure
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
3408
3408
No Patient Involvement
2991
2991
No Consequences Or Impact To Patient
640
640
No Clinical Signs, Symptoms or Conditions
347
347
No Information
98
98
Cardiac Arrest
19
19
Unspecified Infection
19
19
Electric Shock
13
13
Dizziness
10
10
Syncope
10
10
Death
9
9
Ventricular Tachycardia
8
8
Shock
4
4
No Code Available
4
4
Ventricular Fibrillation
4
4
Injury
3
3
Atrial Fibrillation
3
3
Pocket Erosion
3
3
Seizures
3
3
Sepsis
3
3
Endocarditis
2
2
Cardiopulmonary Arrest
2
2
Staphylococcus Aureus
2
2
Shock from Patient Lead(s)
2
2
Arrhythmia
2
2
Tachycardia
2
2
Discomfort
2
2
Complaint, Ill-Defined
1
1
Shaking/Tremors
1
1
Loss Of Pulse
1
1
Not Applicable
1
1
Bacterial Infection
1
1
Bradycardia
1
1
Edema
1
1
Electrocution
1
1
Hemorrhage/Bleeding
1
1
Muscular Rigidity
1
1
Heart Failure
1
1
Convulsion, Clonic
1
1
Infection, Indirect
1
1
Toxoplasmosis, Acquired
1
1
Pregnancy
1
1
Insufficient Information
1
1
Vascular Dissection
1
1
Erosion
1
1
Dyspnea
1
1
Non specific EKG/ECG Changes
1
1
Fainting
1
1
Fall
1
1
Fever
1
1
Failure of Implant
1
1
Renal Failure
1
1
Swelling
1
1
Perforation of Vessels
1
1
Malaise
1
1
Coma
1
1
Loss of consciousness
1
1
Sudden Cardiac Death
1
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Sorin Group USA, Inc.
II
Nov-15-2016
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