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TPLC
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Device
pulse-generator, pacemaker, external
Regulation Description
External pacemaker pulse generator.
Product Code
DTE
Regulation Number
870.3600
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SOLO PACE, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1092
1092
2021
899
899
2022
833
833
2023
650
650
2024
621
621
2025
142
142
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
977
977
Mechanical Problem
668
668
No Display/Image
618
618
Display or Visual Feedback Problem
391
391
Calibration Problem
380
380
Output Problem
287
287
Device Sensing Problem
223
223
Failure to Power Up
218
218
Unexpected Shutdown
211
211
Use of Device Problem
208
208
Break
201
201
No Device Output
189
189
Material Integrity Problem
135
135
Corroded
125
125
Component Missing
115
115
Battery Problem
90
90
Contamination
81
81
Electrical /Electronic Property Problem
73
73
Failure to Capture
63
63
Loose or Intermittent Connection
53
53
Crack
46
46
Capturing Problem
42
42
Power Problem
36
36
Insufficient Information
24
24
Moisture Damage
24
24
Pacing Intermittently
21
21
Failure to Sense
18
18
Adverse Event Without Identified Device or Use Problem
18
18
Failure to Shut Off
13
13
Pacing Problem
13
13
Under-Sensing
12
12
Inadequate User Interface
12
12
Intermittent Capture
12
12
Output below Specifications
9
9
Blocked Connection
8
8
Output above Specifications
8
8
Failure to Calibrate
7
7
Over-Sensing
7
7
Contamination /Decontamination Problem
6
6
Difficult to Insert
6
6
Device Difficult to Program or Calibrate
6
6
Data Problem
5
5
Operating System Becomes Nonfunctional
5
5
Circuit Failure
5
5
Noise, Audible
5
5
Application Program Freezes, Becomes Nonfunctional
4
4
Failure of Device to Self-Test
4
4
No Pacing
4
4
Defective Device
4
4
Sensing Intermittently
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3259
3259
No Patient Involvement
727
727
No Known Impact Or Consequence To Patient
126
126
No Consequences Or Impact To Patient
97
97
Cardiac Arrest
41
41
Ventricular Fibrillation
32
32
Asystole
21
21
Arrhythmia
17
17
Tachycardia
16
16
Heart Block
9
9
Loss of consciousness
9
9
Bradycardia
6
6
Insufficient Information
5
5
Non specific EKG/ECG Changes
4
4
Superficial (First Degree) Burn
4
4
R On T Phenomenon
4
4
Low Blood Pressure/ Hypotension
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Information
3
3
Injury
3
3
Erythema
3
3
Diaphoresis
2
2
Low Oxygen Saturation
2
2
Dizziness
2
2
Skin Inflammation/ Irritation
2
2
Abrasion
2
2
Pericardial Effusion
2
2
Blister
2
2
Pneumonia
2
2
Bruise/Contusion
1
1
Respiratory Failure
1
1
Atrial Flutter
1
1
Hemorrhage/Bleeding
1
1
Unspecified Heart Problem
1
1
Ectopic Heartbeat
1
1
Skin Tears
1
1
Hypoxia
1
1
Shaking/Tremors
1
1
Sudden Cardiac Death
1
1
Stenosis
1
1
Dyspnea
1
1
Cardiopulmonary Arrest
1
1
Discomfort
1
1
Septic Shock
1
1
Cardiac Perforation
1
1
Pallor
1
1
Burn(s)
1
1
Cardiac Tamponade
1
1
Skin Discoloration
1
1
Device Overstimulation of Tissue
1
1
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