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TPLC
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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)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
1
1
2
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
172
172
Device Problems
MDRs with this Device Problem
Events in those MDRs
Key or Button Unresponsive/not Working
800
800
Defective Device
531
531
Communication or Transmission Problem
364
364
Application Program Problem
88
88
Wireless Communication Problem
76
76
Device Operates Differently Than Expected
65
65
Display or Visual Feedback Problem
65
65
Failure to Power Up
60
60
Data Problem
43
43
Defective Component
35
35
Overheating of Device
30
30
Computer Software Problem
27
27
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
20
20
Pacing Problem
18
18
Connection Problem
14
14
No Display/Image
13
13
Application Program Freezes, Becomes Nonfunctional
13
13
Telemetry Discrepancy
10
10
Device Displays Incorrect Message
8
8
Use of Device Problem
8
8
Device Sensing Problem
8
8
Inadequate User Interface
8
8
Incorrect Measurement
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
Insufficient Information
6
6
Mechanical Problem
5
5
Over-Sensing
5
5
Failure to Transmit Record
5
5
Date/Time-Related Software Problem
5
5
Inappropriate/Inadequate Shock/Stimulation
5
5
Ambient Noise Problem
4
4
Failure to Interrogate
4
4
Output Problem
4
4
Device Operational Issue
3
3
Device Packaging Compromised
3
3
Appropriate Term/Code Not Available
3
3
Patient Data Problem
3
3
Program or Algorithm Execution Failure
3
3
Loss of Data
3
3
Failure to Shut Off
3
3
Low impedance
2
2
Capturing Problem
2
2
Smoking
2
2
Under-Sensing
2
2
Device Inoperable
2
2
Detachment Of Device Component
2
2
High impedance
2
2
Premature Discharge of Battery
2
2
Failure to Reset
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
No Device Output
2
2
Program or Algorithm Execution Problem
2
2
Intermittent Loss of Power
2
2
Inappropriate Tactile Prompt/Feedback
2
2
Noise, Audible
2
2
Therapeutic or Diagnostic Output Failure
2
2
Unauthorized Access to Computer System
1
1
Scratched Material
1
1
Packaging Problem
1
1
Operating System Becomes Nonfunctional
1
1
Operating System Version or Upgrade Problem
1
1
Unexpected Shutdown
1
1
Activation Problem
1
1
Melted
1
1
Energy Output Problem
1
1
Shipping Damage or Problem
1
1
Device Difficult to Setup or Prepare
1
1
Product Quality Problem
1
1
Unable to Obtain Readings
1
1
Thermal Decomposition of Device
1
1
Failure to Charge
1
1
Device Alarm System
1
1
Failure to Back-Up
1
1
Unintended Power Up
1
1
Display Difficult to Read
1
1
Erratic or Intermittent Display
1
1
Image Orientation Incorrect
1
1
Difficult to Interrogate
1
1
Loose or Intermittent Connection
1
1
Device Stops Intermittently
1
1
Invalid Sensing
1
1
Component Missing
1
1
Incomplete or Missing Packaging
1
1
Tear, Rip or Hole in Device Packaging
1
1
Application Network Problem
1
1
Low Battery
1
1
Improper or Incorrect Procedure or Method
1
1
Computer System Security Problem
1
1
Human-Device Interface Problem
1
1
Impedance Problem
1
1
Inappropriate or Unexpected Reset
1
1
Installation-Related Problem
1
1
Issue With Displayed Error Message
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1535
1535
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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