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TPLC
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Device
implantable pulse generator, pacemaker (non-crt)
Definition
These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Product Code
LWP
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
78
66
91
123
116
126
97
97
116
97
88
90
70
65
54
31
MDR Year
MDR Reports
MDR Events
2014
9400
9400
2015
9422
9422
2016
12356
12356
2017
11643
11643
2018
14937
14937
2019
9627
9627
2020
8989
8989
2021
9374
9374
2022
14287
14287
2023
12639
12639
2024
7069
7069
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
25615
25615
Premature Discharge of Battery
24535
24535
Device Displays Incorrect Message
12046
12046
High impedance
11729
11729
Over-Sensing
9982
9982
Pacing Problem
6759
6759
Failure to Capture
6262
6262
Pacemaker Found in Back-Up Mode
4527
4527
Device Operates Differently Than Expected
4289
4289
Battery Problem
4262
4262
Defective Device
4177
4177
Incorrect, Inadequate or Imprecise Result or Readings
3385
3385
Signal Artifact/Noise
3260
3260
Device Dislodged or Dislocated
3222
3222
Ambient Noise Problem
3186
3186
Device Sensing Problem
2969
2969
High Capture Threshold
2922
2922
Capturing Problem
2663
2663
Low impedance
2619
2619
Material Integrity Problem
2579
2579
Under-Sensing
2137
2137
Failure to Interrogate
2041
2041
Connection Problem
2012
2012
Device Alarm System
2005
2005
Appropriate Term/Code Not Available
1834
1834
Nonstandard Device
1710
1710
Mechanical Problem
1322
1322
Noise, Audible
1271
1271
Inappropriate/Inadequate Shock/Stimulation
1210
1210
Impedance Problem
1149
1149
Output Problem
839
839
Communication or Transmission Problem
778
778
Inappropriate or Unexpected Reset
773
773
Electrical /Electronic Property Problem
752
752
Incorrect Measurement
735
735
No Display/Image
732
732
No Pacing
732
732
No Device Output
719
719
Pocket Stimulation
713
713
Use of Device Problem
640
640
Data Problem
633
633
Telemetry Discrepancy
624
624
Interrogation Problem
595
595
Fracture
532
532
Failure to Read Input Signal
530
530
Break
441
441
Human-Device Interface Problem
424
424
No Apparent Adverse Event
414
414
Insufficient Information
414
414
Positioning Problem
394
394
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
34794
34794
No Clinical Signs, Symptoms or Conditions
32009
32009
No Consequences Or Impact To Patient
17827
17827
Unspecified Infection
14167
14167
No Code Available
4683
4683
No Patient Involvement
3528
3528
Sepsis
3085
3085
Insufficient Information
2557
2557
Syncope
2011
2011
Pocket Erosion
1743
1743
Dizziness
1322
1322
Death
1227
1227
Complaint, Ill-Defined
1125
1126
Muscle Stimulation
1111
1111
Syncope/Fainting
852
852
Arrhythmia
811
811
Bradycardia
806
806
Cardiac Arrest
742
742
Discomfort
700
700
Atrial Fibrillation
638
638
Dyspnea
565
565
Electric Shock
560
560
Asystole
542
542
Erosion
542
542
Fatigue
540
540
Pain
498
499
Bacterial Infection
458
458
No Information
458
458
Device Overstimulation of Tissue
453
453
Endocarditis
409
409
Fall
408
408
Hematoma
387
387
Ventricular Tachycardia
354
354
Cardiac Perforation
314
314
Staphylococcus Aureus
292
292
Ventricular Fibrillation
273
273
Chest Pain
265
265
Undesired Nerve Stimulation
262
262
Palpitations
205
205
Wound Dehiscence
195
195
Pericardial Effusion
178
178
Twiddlers Syndrome
178
178
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
164
164
Fever
162
162
Heart Failure
156
156
Tachycardia
142
142
Swelling
126
126
Purulent Discharge
121
121
Complete Heart Block
118
118
Low Blood Pressure/ Hypotension
111
111
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific CRM Corp
II
Oct-18-2014
2
Boston Scientific CRM Corp
II
Oct-17-2013
3
Boston Scientific CRM Corp
II
Oct-07-2010
4
Boston Scientific CRM Corp
II
May-08-2010
5
Boston Scientific CRM Corp
II
Jan-13-2010
6
Boston Scientific CRM Corp
II
Aug-18-2009
7
Boston Scientific CRM Corp
II
Jul-17-2009
8
Boston Scientific CRM Corp
II
Jul-14-2009
9
Boston Scientific Corporation
I
Jul-13-2021
10
Boston Scientific Corporation
II
Jul-02-2021
11
Boston Scientific Corporation
II
Jan-15-2018
12
Boston Scientific Corporation
II
Dec-30-2016
13
Boston Scientific Corporation
II
Sep-07-2016
14
Medtronic Inc. Cardiac Rhythm Disease Management
II
May-24-2014
15
Medtronic Inc. Cardiac Rhythm Disease Managment
II
Nov-22-2010
16
St Jude Medical Inc.
II
Jun-12-2018
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