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TPLC
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Device
pulse generator, permanent, implantable
Definition
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Product Code
NVZ
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
124
181
178
130
131
122
88
76
61
59
60
73
40
44
39
13
MDR Year
MDR Reports
MDR Events
2014
3106
3106
2015
2773
2773
2016
2554
2554
2017
3164
3164
2018
5877
5877
2019
8186
8186
2020
8337
8337
2021
8537
8537
2022
7791
7791
2023
8464
8464
2024
2278
2278
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
12928
12928
Premature Discharge of Battery
7595
7595
Pacing Problem
6295
6295
Appropriate Term/Code Not Available
4644
4644
Battery Problem
4025
4025
Over-Sensing
4011
4011
Failure to Interrogate
3172
3172
Mechanical Problem
2510
2510
Inappropriate or Unexpected Reset
1510
1510
Unable to Obtain Readings
1501
1501
Failure to Capture
1465
1465
Incorrect Measurement
1285
1285
Pacemaker Found in Back-Up Mode
1200
1200
Inappropriate/Inadequate Shock/Stimulation
1062
1062
Defective Device
1029
1029
Signal Artifact/Noise
908
908
Under-Sensing
860
860
Overheating of Device
837
837
Communication or Transmission Problem
834
834
Reset Problem
812
812
High impedance
772
772
Device Sensing Problem
703
703
Migration or Expulsion of Device
682
682
Nonstandard Device
596
596
False Alarm
549
549
Insufficient Information
537
537
No Pacing
524
524
Incorrect Interpretation of Signal
511
511
Premature Elective Replacement Indicator
468
468
Electromagnetic Interference
457
457
Output Problem
438
438
Data Problem
423
423
Low impedance
406
406
Capturing Problem
391
391
High Capture Threshold
338
338
Loose or Intermittent Connection
300
300
Misconnection
293
293
Device Operates Differently Than Expected
283
283
Impedance Problem
281
281
Battery Problem: High Impedance
254
254
Electrical /Electronic Property Problem
244
244
Use of Device Problem
210
210
Break
196
196
Connection Problem
194
194
Failure to Deliver Shock/Stimulation
186
186
Missing Test Results
183
183
False Positive Result
176
176
Failure to Charge
172
172
Failure to Disconnect
161
161
Intermittent Capture
158
158
Delayed Charge Time
149
149
Protective Measures Problem
146
146
Interrogation Problem
141
141
Device Displays Incorrect Message
141
141
Thermal Decomposition of Device
124
124
Incorrect, Inadequate or Imprecise Result or Readings
121
121
Device-Device Incompatibility
121
121
Failure to Convert Rhythm
101
101
Therapeutic or Diagnostic Output Failure
100
100
Premature End-of-Life Indicator
95
95
Pocket Stimulation
92
92
Pacing Asynchronously
89
89
Pacing Inadequately
89
89
Device Emits Odor
89
89
Wireless Communication Problem
87
87
Difficult to Remove
84
84
Device Dislodged or Dislocated
78
78
Display or Visual Feedback Problem
76
76
Positioning Problem
73
73
Failure to Sense
68
68
Noise, Audible
67
67
Invalid Sensing
65
65
Output above Specifications
62
62
Battery Impedance Issue
62
62
Low Battery
58
58
Component Missing
55
55
Therapy Delivered to Incorrect Body Area
53
53
Pacing Intermittently
52
52
Telemetry Discrepancy
49
49
Unstable Capture Threshold
49
49
Environmental Compatibility Problem
47
47
No Apparent Adverse Event
44
44
Difficult to Interrogate
42
42
Device Contamination with Body Fluid
40
40
Migration
40
40
Ambient Noise Problem
39
39
Loss of Data
38
38
Decreased Sensitivity
37
37
Failure to Power Up
34
34
Fitting Problem
33
33
Defibrillation/Stimulation Problem
32
32
Device Markings/Labelling Problem
30
30
Energy Output Problem
29
29
Device Expiration Issue
28
28
Defective Alarm
28
28
Packaging Problem
28
28
Power Problem
27
27
Charging Problem
25
25
Fracture
25
25
No Device Output
25
25
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
18806
18810
No Clinical Signs, Symptoms or Conditions
15909
15909
Unspecified Infection
8026
8026
No Consequences Or Impact To Patient
2370
2370
Insufficient Information
2029
2029
Bradycardia
2020
2020
Dizziness
1175
1175
Death
1144
1144
Arrhythmia
964
964
Discomfort
916
916
Syncope
861
861
Pocket Erosion
822
822
Dyspnea
789
789
Syncope/Fainting
780
780
Pain
696
696
No Code Available
554
554
No Information
532
532
Therapeutic Effects, Unexpected
523
523
Cardiac Arrest
491
491
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
471
471
Chest Pain
466
466
Fatigue
462
462
Erosion
449
449
Tachycardia
436
436
Complaint, Ill-Defined
421
421
Endocarditis
398
398
Sepsis
395
395
Bacterial Infection
389
389
Hematoma
377
377
Atrial Fibrillation
320
320
Fall
316
316
Non specific EKG/ECG Changes
270
270
Palpitations
247
247
Wound Dehiscence
240
240
No Patient Involvement
206
206
Erythema
201
201
Fever
190
190
Heart Block
175
175
Swelling/ Edema
158
158
Ventricular Tachycardia
151
151
Ventricular Fibrillation
144
144
Muscle Stimulation
143
143
Weakness
136
136
Low Blood Pressure/ Hypotension
122
122
Asystole
115
115
Muscle Weakness
112
112
Purulent Discharge
105
105
Swelling
97
97
Device Overstimulation of Tissue
92
92
Hypersensitivity/Allergic reaction
87
87
Loss of consciousness
84
84
Foreign Body In Patient
83
83
Heart Failure/Congestive Heart Failure
72
72
Impaired Healing
68
68
Complete Heart Block
67
67
Presyncope
67
67
Nausea
67
67
Heart Failure
65
65
Cardiomyopathy
63
63
Fainting
62
62
Undesired Nerve Stimulation
62
62
Inflammation
61
61
Pericardial Effusion
61
61
Exit Block
60
60
Twiddlers Syndrome
60
60
Drug Resistant Bacterial Infection
60
60
Fluid Discharge
55
55
Burning Sensation
54
54
Chest Tightness/Pressure
53
53
High Blood Pressure/ Hypertension
52
52
Stroke/CVA
52
52
Myocardial Infarction
51
51
Failure of Implant
49
49
Shock from Patient Lead(s)
49
49
Anxiety
47
47
Atrial Flutter
47
47
Headache
45
45
Pneumothorax
45
45
Septic Shock
43
43
Lethargy
42
42
Electric Shock
37
37
Hemorrhage/Bleeding
37
37
Bruise/Contusion
35
35
Burn(s)
34
34
Sleep Dysfunction
34
34
Implant Pain
34
34
Numbness
33
33
Itching Sensation
33
33
Rash
32
32
Pneumonia
32
32
Convulsion/Seizure
32
32
Vomiting
31
31
Congestive Heart Failure
31
31
Seizures
29
29
Twitching
29
29
Confusion/ Disorientation
28
28
Diaphoresis
27
27
Thrombosis/Thrombus
27
27
Twiddlers Syndrome
26
26
Hypoxia
26
26
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Inc. Cardiac Rhythm Disease Management
II
Apr-29-2011
2
Medtronic Inc. Cardiac Rhythm Disease Managment
II
Aug-11-2010
3
Medtronic Inc. Cardiac Rhythm Disease Managment
I
Jun-11-2009
4
Medtronic Inc., Cardiac Rhythm and Heart Failure
II
Jan-19-2018
5
Medtronic Inc., Cardiac Rhythm and Heart Failure
II
Jul-05-2016
6
Medtronic Inc., Cardiac Rhythm and Heart Failure
II
May-04-2016
7
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Dec-16-2021
8
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jul-10-2020
9
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Feb-14-2019
10
St Jude Medical Cardiac Rhythm Management Division
II
Sep-28-2015
11
St Jude Medical Cardiac Rhythm Management Division
II
Jan-09-2015
12
St Jude Medical, Cardiac Rhythm Management Division
II
Feb-24-2020
13
St. Jude Medical, Cardian Rhythm Management Division
I
May-07-2021
14
ela Medical Llc
II
Sep-24-2009
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