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TPLC
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show TPLC since
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2024
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Device
pacemaker lead adaptor
Product Code
DTD
Regulation Number
870.3620
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
34
34
2020
19
19
2021
23
23
2022
25
25
2023
28
28
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
60
60
Over-Sensing
12
12
High impedance
11
11
Signal Artifact/Noise
8
8
Ambient Noise Problem
7
7
High Capture Threshold
7
7
Failure to Capture
6
6
Impedance Problem
5
5
Connection Problem
4
4
Low impedance
4
4
Break
4
4
Fracture
3
3
Use of Device Problem
3
3
Capturing Problem
3
3
Device Sensing Problem
3
3
Material Integrity Problem
2
2
Under-Sensing
2
2
Detachment of Device or Device Component
2
2
Off-Label Use
2
2
Noise, Audible
2
2
Device Fell
1
1
Unstable Capture Threshold
1
1
Retraction Problem
1
1
Failure to Sense
1
1
Material Separation
1
1
Loose or Intermittent Connection
1
1
Mechanical Problem
1
1
Pacing Problem
1
1
Device Alarm System
1
1
Difficult or Delayed Positioning
1
1
Intermittent Capture
1
1
Premature Discharge of Battery
1
1
Battery Problem
1
1
High Sensing Threshold
1
1
Mechanical Jam
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
48
48
No Clinical Signs, Symptoms or Conditions
34
34
No Known Impact Or Consequence To Patient
22
22
Insufficient Information
7
7
Erosion
5
5
Sepsis
5
5
No Consequences Or Impact To Patient
5
5
Pocket Erosion
4
4
Failure of Implant
3
3
Fluid Discharge
2
2
Endocarditis
2
2
Therapeutic Response, Decreased
2
2
Skin Inflammation
1
1
Respiratory Failure
1
1
Cardiac Perforation
1
1
Cardiac Tamponade
1
1
Skin Erosion
1
1
Burning Sensation
1
1
Head Injury
1
1
Hematoma
1
1
Chest Pain
1
1
Death
1
1
Wound Dehiscence
1
1
Arrhythmia
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Pericardial Effusion
1
1
Heart Failure/Congestive Heart Failure
1
1
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