Programmer, Pacemaker

Device Code: 854

Product Code(s): KRG

Device Classification Information

Device Type ID854
Device NameProgrammer, Pacemaker
Regulation DescriptionPacemaker Programmers.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission TypePMA
CFR Regulation Number870.3700 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeKRG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID854
DeviceProgrammer, Pacemaker
Product CodeKRG
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionPacemaker Programmers.
CFR Regulation Number870.3700 [🔎]
Device Problems
Device Difficult To Program Or Calibrate
 827
No Display / Image
 568
Computer Operating System Problem
 477
Device Operates Differently Than Expected
 346
Failure To Calibrate
 337
Computer Software Problem
 317
Power Problem
 286
Inadequate User Interface
 248
Communication Or Transmission Problem
 233
Output Problem
 195
Overheating Of Device
 169
Electrical /Electronic Property Problem
 161
Connection Problem
 157
Mechanical Problem
 150
Problem With Software Installation
 126
Incorrect Measurement
 117
Failure To Power Up
 116
Data Problem
 104
Signal Artifact
 99
Adverse Event Without Identified Device Or Use Problem
 99
Unexpected Shutdown
 89
Noise, Audible
 85
Break
 84
Material Integrity Problem
 75
Failure To Interrogate
70
High Impedance
 66
Display Or Visual Feedback Problem
 65
Operating System Becomes Nonfunctional
 62
Device Sensing Problem
 58
Application Interface Becomes Non-Functional Or Program Exits Abnormally
 57
Loose Or Intermittent Connection
 50
Over-Sensing
 49
Ambient Noise Problem
 43
Crack
 42
Corroded
37
Device Displays Incorrect Message
36
Inappropriate Shock
 31
Contamination During Use
 26
Calibration Problem
 26
No Device Output
26
Device Emits Odor
 26
Battery Problem
 25
Use Of Device Problem
 23
Impedance Problem
 23
Failure To Capture
 19
Capturing Problem
 16
Thermal Decomposition Of Device
 16
Degraded
 15
Failure To Sense
15
Low Impedance
 14
Premature Discharge Of Battery
13
Pacing Problem
 13
Electrical Shorting
 13
Device Contamination With Chemical Or Other Material
 11
Erratic Or Intermittent Display
 11
Component Missing
11
Programmer
 10
Device Operational Issue
 10
Insufficient Information
 10
Telemetry Discrepancy
 8
Issue With Displayed Error Message
 8
No Audible Alarm
 7
Appropriate Term/Code Not Available
 7
Application Program Freezes, Becomes Nonfunctional
7
Under-Sensing
7
Failure To Shut Off
 7
Device Alarm System
 7
Structural Problem
 6
Display Difficult To Read
6
Incorrect Software Programming Calculations
 6
Interrogation Problem
 6
Defibrillation Problem
 5
Blocked Connection
 5
Incorrect Or Inadequate Test Results
 5
Wireless Communication Problem
 5
Delayed Program Or Algorithm Execution
 4
Operating System Version Or Upgrade Problem
 4
Application Program Version Or Upgrade Problem
 4
Date/Time-Related Software Problem
 4
Screen
 4
Intermittent Communication Failure
 3
No Apparent Adverse Event
 3
Sparking
 3
Bent
 3
Device Stops Intermittently
 3
Electromagnetic Interference
 3
Device Contamination With Biological Material
 3
Incorrect, Inadequate Or Imprecise Result Or Readings
 3
Difficult To Insert
 3
Moisture Damage
 2
Failure To Align
 2
Protective Measures Problem
 2
Intermittent Loss Of Power
 2
Component Or Accessory Incompatibility
2
Loss Of Power
 2
Failure To Read Input Signal
 2
Difficult To Interrogate
 2
Improper Device Output
 2
Human-Device Interface Problem
 2
Programming Issue
 2
Total Device Problems 6674
Recalls
Manufacturer Recall Class Date Posted
1
Sorin Group USA, Inc.
 II Nov-15-2016
TPLC Last Update: 2019-04-02 19:43:31
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