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Device
pacemaker/icd/crt non-implanted components
Definition
Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Product Code
OSR
Device Class
3
Premarket Approvals (PMA)
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
8
8
3
1
0
0
0
2
1
3
0
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
46
46
2016
29
29
2017
40
40
2018
57
57
2019
39
39
2020
39
39
2021
100
100
2022
257
257
2023
1065
1065
2024
120
120
Device Problems
MDRs with this Device Problem
Events in those MDRs
Key or Button Unresponsive/not Working
782
782
Defective Device
510
510
Communication or Transmission Problem
352
352
Application Program Problem
85
85
Wireless Communication Problem
72
72
Device Operates Differently Than Expected
65
65
Display or Visual Feedback Problem
64
64
Failure to Power Up
59
59
Data Problem
42
42
Defective Component
35
35
Overheating of Device
30
30
Computer Software Problem
26
26
Computer Operating System Problem
22
22
No Apparent Adverse Event
22
22
Detachment of Device or Device Component
21
21
Power Problem
20
20
Interrogation Problem
19
19
Pacing Problem
18
18
Connection Problem
14
14
No Display/Image
13
13
Application Program Freezes, Becomes Nonfunctional
9
9
Telemetry Discrepancy
9
9
Inadequate User Interface
8
8
Device Displays Incorrect Message
8
8
Incorrect Measurement
8
8
Use of Device Problem
8
8
Device Sensing Problem
8
8
Material Integrity Problem
8
8
Battery Problem
7
7
Electrical /Electronic Property Problem
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Failure to Transmit Record
5
5
Inappropriate/Inadequate Shock/Stimulation
5
5
Over-Sensing
5
5
Date/Time-Related Software Problem
5
5
Insufficient Information
5
5
Mechanical Problem
4
4
Output Problem
4
4
Ambient Noise Problem
4
4
Failure to Interrogate
4
4
Appropriate Term/Code Not Available
3
3
Device Operational Issue
3
3
Program or Algorithm Execution Failure
3
3
Loss of Data
3
3
Failure to Shut Off
3
3
Patient Data Problem
3
3
Device Packaging Compromised
3
3
Under-Sensing
2
2
Program or Algorithm Execution Problem
2
2
Intermittent Loss of Power
2
2
Inappropriate Tactile Prompt/Feedback
2
2
Detachment Of Device Component
2
2
Noise, Audible
2
2
No Device Output
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Device Inoperable
2
2
Low impedance
2
2
Capturing Problem
2
2
Smoking
2
2
Therapeutic or Diagnostic Output Failure
2
2
Failure to Reset
2
2
High impedance
2
2
Premature Discharge of Battery
2
2
Invalid Sensing
1
1
Inappropriate or Unexpected Reset
1
1
Unintended Power Up
1
1
Unauthorized Access to Computer System
1
1
Activation Problem
1
1
Device Difficult to Setup or Prepare
1
1
Failure to Charge
1
1
Shipping Damage or Problem
1
1
Component Missing
1
1
Melted
1
1
Issue With Displayed Error Message
1
1
Device Stops Intermittently
1
1
Tear, Rip or Hole in Device Packaging
1
1
Product Quality Problem
1
1
Display Difficult to Read
1
1
Energy Output Problem
1
1
Difficult to Interrogate
1
1
Improper or Incorrect Procedure or Method
1
1
Human-Device Interface Problem
1
1
Operating System Becomes Nonfunctional
1
1
Computer System Security Problem
1
1
Packaging Problem
1
1
Scratched Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Impedance Problem
1
1
Loose or Intermittent Connection
1
1
Erratic or Intermittent Display
1
1
Unable to Obtain Readings
1
1
Device Alarm System
1
1
Low Battery
1
1
Failure to Back-Up
1
1
Installation-Related Problem
1
1
Application Network Problem
1
1
Incomplete or Missing Packaging
1
1
Operating System Version or Upgrade Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1483
1483
No Known Impact Or Consequence To Patient
124
124
No Information
54
54
Insufficient Information
45
45
No Consequences Or Impact To Patient
45
45
No Patient Involvement
40
40
Asystole
9
9
Bradycardia
5
5
Syncope/Fainting
4
4
Complaint, Ill-Defined
3
3
Electric Shock
3
3
Arrhythmia
3
3
Unspecified Infection
3
3
Tachycardia
2
2
Head Injury
2
2
Cardiac Arrest
2
2
Dyspnea
2
2
Fall
2
2
Syncope
2
2
Shock from Patient Lead(s)
2
2
Heart Failure/Congestive Heart Failure
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Swelling/ Edema
1
1
Fever
1
1
Cardiomyopathy
1
1
Death
1
1
Atrial Fibrillation
1
1
Atrial Flutter
1
1
Burn(s)
1
1
Failure of Implant
1
1
Discomfort
1
1
Ventricular Fibrillation
1
1
Dizziness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Nov-24-2021
2
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Apr-30-2021
3
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Mar-19-2020
4
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Oct-30-2019
5
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Feb-16-2019
6
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Feb-02-2019
7
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Nov-08-2018
8
St Jude Medical Inc.
II
Jun-29-2018
9
St Jude Medical Inc.
II
Jun-12-2018
10
St. Jude Medical, Cardiac Rhythm Management Division
II
Apr-21-2022
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