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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)
2019
2020
2021
2022
2023
2024
0
0
2
1
3
0
MDR Year
MDR Reports
MDR Events
2019
39
39
2020
39
39
2021
100
100
2022
257
257
2023
1065
1065
2024
85
85
Device Problems
MDRs with this Device Problem
Events in those MDRs
Key or Button Unresponsive/not Working
767
767
Defective Device
498
498
Communication or Transmission Problem
335
335
Application Program Problem
77
77
Wireless Communication Problem
66
66
Display or Visual Feedback Problem
64
64
Failure to Power Up
43
43
Data Problem
40
40
Defective Component
35
35
Overheating of Device
29
29
Detachment of Device or Device Component
21
21
Interrogation Problem
19
19
Connection Problem
14
14
Computer Software Problem
14
14
No Display/Image
12
12
Pacing Problem
10
10
Application Program Freezes, Becomes Nonfunctional
9
9
Telemetry Discrepancy
8
8
Incorrect Measurement
7
7
Device Sensing Problem
7
7
Material Integrity Problem
6
6
No Apparent Adverse Event
6
6
Use of Device Problem
6
6
Electrical /Electronic Property Problem
5
5
Power Problem
5
5
Date/Time-Related Software Problem
5
5
Computer Operating System Problem
4
4
Insufficient Information
4
4
Failure to Transmit Record
4
4
Loss of Data
3
3
Device Displays Incorrect Message
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Program or Algorithm Execution Failure
3
3
Appropriate Term/Code Not Available
2
2
Therapeutic or Diagnostic Output Failure
2
2
Program or Algorithm Execution Problem
2
2
Inappropriate Tactile Prompt/Feedback
2
2
Patient Data Problem
2
2
Noise, Audible
2
2
Intermittent Loss of Power
2
2
Failure to Reset
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Smoking
2
2
Mechanical Problem
2
2
Over-Sensing
2
2
Failure to Back-Up
1
1
Premature Discharge of Battery
1
1
Failure to Charge
1
1
Melted
1
1
Energy Output Problem
1
1
No Device Output
1
1
Difficult to Interrogate
1
1
Loose or Intermittent Connection
1
1
Unintended Power Up
1
1
Display Difficult to Read
1
1
Erratic or Intermittent Display
1
1
Improper or Incorrect Procedure or Method
1
1
Low impedance
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
Unauthorized Access to Computer System
1
1
Scratched Material
1
1
Operating System Version or Upgrade Problem
1
1
Output Problem
1
1
Packaging Problem
1
1
Human-Device Interface Problem
1
1
Impedance Problem
1
1
Inappropriate or Unexpected Reset
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Application Network Problem
1
1
Component Missing
1
1
Incomplete or Missing Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1449
1449
Insufficient Information
44
44
No Information
38
38
No Known Impact Or Consequence To Patient
32
32
No Consequences Or Impact To Patient
14
14
Asystole
9
9
Bradycardia
5
5
Syncope/Fainting
4
4
Electric Shock
3
3
No Patient Involvement
2
2
Shock from Patient Lead(s)
2
2
Tachycardia
2
2
Arrhythmia
2
2
Cardiac Arrest
2
2
Head Injury
2
2
Heart Failure/Congestive Heart Failure
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Swelling/ Edema
1
1
Failure of Implant
1
1
Unspecified Infection
1
1
Dyspnea
1
1
Fall
1
1
Syncope
1
1
Burn(s)
1
1
Ventricular Fibrillation
1
1
Discomfort
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
St. Jude Medical, Cardiac Rhythm Management Division
II
Apr-21-2022
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