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TPLC
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show TPLC since
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2024
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Device
defibrillator, implantable, dual-chamber
Product Code
MRM
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
20
23
18
9
20
13
MDR Year
MDR Reports
MDR Events
2019
345
345
2020
316
316
2021
575
575
2022
505
505
2023
557
557
2024
390
390
Device Problems
MDRs with this Device Problem
Events in those MDRs
Premature Elective Replacement Indicator
1004
1004
Adverse Event Without Identified Device or Use Problem
440
440
Premature End-of-Life Indicator
365
365
Over-Sensing
149
149
Battery Problem
120
120
Failure to Interrogate
119
119
Inappropriate/Inadequate Shock/Stimulation
94
94
High impedance
59
59
Premature Discharge of Battery
45
45
Display or Visual Feedback Problem
39
39
Low impedance
29
29
Application Program Freezes, Becomes Nonfunctional
28
28
Communication or Transmission Problem
24
24
Insufficient Information
23
23
Data Problem
21
21
Inappropriate or Unexpected Reset
17
17
Failure to Deliver Shock/Stimulation
17
17
Computer Software Problem
17
17
Device Displays Incorrect Message
16
16
Interrogation Problem
14
14
Pacemaker Found in Back-Up Mode
10
10
High Capture Threshold
9
9
Ambient Noise Problem
9
9
Device Sensing Problem
9
9
Incorrect, Inadequate or Imprecise Result or Readings
9
9
Migration or Expulsion of Device
9
9
No Pacing
8
8
Connection Problem
8
8
Impedance Problem
8
8
Appropriate Term/Code Not Available
8
8
Failure to Capture
7
7
Signal Artifact/Noise
7
7
Fracture
7
7
Loss of Data
7
7
Unexpected Therapeutic Results
7
7
Nonstandard Device
7
7
Delayed Charge Time
6
6
Pacing Problem
6
6
Program or Algorithm Execution Problem
6
6
Electromagnetic Interference
6
6
Defective Component
6
6
Erratic or Intermittent Display
5
5
Under-Sensing
5
5
Device Markings/Labelling Problem
5
5
Installation-Related Problem
5
5
Wireless Communication Problem
5
5
Application Program Problem
5
5
Defibrillation/Stimulation Problem
5
5
Unexpected Shutdown
4
4
Mechanical Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1680
1680
Unspecified Infection
352
352
No Known Impact Or Consequence To Patient
214
214
No Information
146
146
Insufficient Information
69
69
Shock from Patient Lead(s)
38
38
Pocket Erosion
25
25
Death
19
19
No Patient Involvement
17
17
Ventricular Fibrillation
17
17
No Consequences Or Impact To Patient
12
12
Electric Shock
11
11
Tachycardia
11
11
Ventricular Tachycardia
11
11
Bacterial Infection
9
9
Sepsis
9
9
Syncope/Fainting
8
8
Endocarditis
8
8
Hematoma
8
8
Implant Pain
8
8
Discomfort
8
8
Atrial Fibrillation
8
8
Dizziness
7
7
Pain
7
7
Dyspnea
7
7
Cardiac Arrest
6
6
Arrhythmia
5
5
Failure of Implant
5
5
Shock
5
5
Chest Pain
5
5
Pneumothorax
4
4
Hemorrhage/Bleeding
3
3
Anxiety
3
3
Asystole
3
3
Pneumonia
3
3
Bradycardia
3
3
Fever
3
3
Wound Dehiscence
3
3
Distress
2
2
Staphylococcus Aureus
2
2
Bruise/Contusion
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Loss of consciousness
2
2
Burning Sensation
2
2
Foreign Body In Patient
2
2
Swelling
2
2
Twiddlers Syndrome
2
2
Perforation
2
2
Inflammation
2
2
Swelling/ Edema
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
BIOTRONIK Inc
II
Apr-21-2021
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