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TPLC
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show TPLC since
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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
23
MDR Year
MDR Reports
MDR Events
2014
3107
3107
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
8466
8466
2024
4394
4394
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
13479
13479
Premature Discharge of Battery
7831
7831
Pacing Problem
6679
6679
Appropriate Term/Code Not Available
4792
4792
Over-Sensing
4125
4125
Battery Problem
4048
4048
Failure to Interrogate
3288
3288
Mechanical Problem
2582
2582
Inappropriate or Unexpected Reset
1543
1543
Unable to Obtain Readings
1529
1529
Failure to Capture
1511
1511
Incorrect Measurement
1306
1306
Pacemaker Found in Back-Up Mode
1200
1200
Inappropriate/Inadequate Shock/Stimulation
1101
1101
Defective Device
1077
1077
Signal Artifact/Noise
930
930
Under-Sensing
885
885
Communication or Transmission Problem
857
857
Overheating of Device
850
850
Reset Problem
847
847
High impedance
790
790
Migration or Expulsion of Device
721
721
Device Sensing Problem
711
711
False Alarm
606
606
Nonstandard Device
596
596
Insufficient Information
563
563
No Pacing
544
544
Incorrect Interpretation of Signal
531
531
Electromagnetic Interference
488
488
Premature Elective Replacement Indicator
473
473
Output Problem
447
447
Data Problem
428
428
Low impedance
423
423
Capturing Problem
400
400
High Capture Threshold
346
346
Loose or Intermittent Connection
320
320
Misconnection
301
301
Impedance Problem
290
290
Device Operates Differently Than Expected
283
283
Electrical /Electronic Property Problem
261
261
Battery Problem: High Impedance
256
256
Use of Device Problem
218
218
Break
200
200
Failure to Deliver Shock/Stimulation
194
194
Connection Problem
194
194
Missing Test Results
187
187
False Positive Result
178
178
Failure to Charge
176
176
Failure to Disconnect
170
170
Intermittent Capture
161
161
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
16930
16930
Unspecified Infection
8412
8412
No Consequences Or Impact To Patient
2370
2370
Bradycardia
2219
2219
Insufficient Information
2137
2137
Dizziness
1228
1228
Death
1144
1144
Arrhythmia
1039
1039
Discomfort
992
992
Pocket Erosion
879
879
Syncope
861
861
Syncope/Fainting
849
849
Dyspnea
830
830
Pain
734
734
No Code Available
554
554
No Information
532
532
Therapeutic Effects, Unexpected
523
523
Cardiac Arrest
503
503
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
502
502
Chest Pain
502
502
Erosion
486
486
Fatigue
474
474
Tachycardia
458
458
Bacterial Infection
425
425
Complaint, Ill-Defined
421
421
Sepsis
412
412
Endocarditis
410
410
Hematoma
389
389
Fall
330
330
Atrial Fibrillation
325
325
Non specific EKG/ECG Changes
285
285
Wound Dehiscence
261
261
Erythema
256
256
Palpitations
247
247
Fever
211
211
No Patient Involvement
206
206
Swelling/ Edema
203
203
Heart Block
193
193
Ventricular Tachycardia
151
151
Ventricular Fibrillation
147
147
Purulent Discharge
143
143
Muscle Stimulation
143
143
Weakness
136
136
Asystole
136
136
Low Blood Pressure/ Hypotension
133
133
Muscle Weakness
124
124
Device Overstimulation of Tissue
99
99
Swelling
97
97
Loss of consciousness
92
92
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Inc.
II
Sep-13-2024
2
Medtronic Inc. Cardiac Rhythm Disease Management
II
Apr-29-2011
3
Medtronic Inc. Cardiac Rhythm Disease Managment
II
Aug-11-2010
4
Medtronic Inc. Cardiac Rhythm Disease Managment
I
Jun-11-2009
5
Medtronic Inc., Cardiac Rhythm and Heart Failure
II
Jan-19-2018
6
Medtronic Inc., Cardiac Rhythm and Heart Failure
II
Jul-05-2016
7
Medtronic Inc., Cardiac Rhythm and Heart Failure
II
May-04-2016
8
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Dec-16-2021
9
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
II
Jul-10-2020
10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
I
Feb-14-2019
11
St Jude Medical Cardiac Rhythm Management Division
II
Sep-28-2015
12
St Jude Medical Cardiac Rhythm Management Division
II
Jan-09-2015
13
St Jude Medical, Cardiac Rhythm Management Division
II
Feb-24-2020
14
St. Jude Medical, Cardian Rhythm Management Division
I
May-07-2021
15
ela Medical Llc
II
Sep-24-2009
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