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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable cardioverter defibrillator (non-crt)
Definition These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Product CodeLWS
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
98 125 111 91 101 98

MDR Year MDR Reports MDR Events
2019 16186 16186
2020 16910 16910
2021 19658 19658
2022 23462 23462
2023 28724 28724
2024 23074 23075

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 30840 30840
High impedance 20207 20207
Adverse Event Without Identified Device or Use Problem 19580 19580
Inappropriate/Inadequate Shock/Stimulation 18002 18002
Premature Discharge of Battery 17475 17475
Signal Artifact/Noise 15672 15672
Fracture 9042 9042
Impedance Problem 7183 7183
High Capture Threshold 7008 7008
Device Sensing Problem 6719 6719
Incorrect, Inadequate or Imprecise Result or Readings 6511 6511
Battery Problem 5460 5460
Failure to Read Input Signal 5039 5039
Under-Sensing 5036 5036
Pacing Problem 4981 4981
Low impedance 3868 3868
Device Dislodged or Dislocated 2998 2998
Failure to Capture 2811 2811
Defective Device 2608 2608
Decreased Sensitivity 2385 2385
Premature Elective Replacement Indicator 2367 2368
Capturing Problem 1957 1957
Noise, Audible 1577 1577
Appropriate Term/Code Not Available 1317 1317
Failure to Convert Rhythm 1282 1282
Break 1201 1201
Inappropriate or Unexpected Reset 1176 1176
Mechanical Problem 1148 1148
Electromagnetic Interference 1043 1043
Data Problem 1013 1013
Electrical /Electronic Property Problem 939 939
Material Integrity Problem 936 936
Failure to Interrogate 864 864
Connection Problem 842 842
Failure to Deliver Shock/Stimulation 718 718
Defibrillation/Stimulation Problem 705 705
Inaccurate Synchronization 696 696
Interrogation Problem 678 678
Positioning Problem 658 658
Premature End-of-Life Indicator 637 637
Insufficient Information 609 609
Migration 580 580
Unstable Capture Threshold 580 580
No Apparent Adverse Event 547 547
Positioning Failure 546 546
Activation, Positioning or Separation Problem 538 538
Unexpected Therapeutic Results 445 445
Delayed Charge Time 418 418
Failure to Charge 380 380
Incorrect Interpretation of Signal 375 375

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 61019 61020
Unspecified Infection 15780 15780
No Known Impact Or Consequence To Patient 15071 15071
Shock from Patient Lead(s) 8822 8822
Electric Shock 7936 7936
No Consequences Or Impact To Patient 5410 5410
Insufficient Information 3710 3710
No Code Available 3469 3469
Sepsis 2206 2206
Pocket Erosion 1287 1287
Discomfort 1003 1003
Arrhythmia 939 939
Syncope/Fainting 930 930
Ventricular Fibrillation 930 930
Pain 913 913
Erosion 755 755
Bacterial Infection 729 729
Bradycardia 727 727
Tachycardia 708 708
Dizziness 691 691
Chest Pain 573 573
Hematoma 557 557
Endocarditis 535 535
Dyspnea 505 505
Cardiac Arrest 466 466
Wound Dehiscence 465 465
Cardiac Perforation 455 455
Death 443 443
Swelling/ Edema 435 435
Purulent Discharge 400 400
Erythema 366 366
Fever 364 364
Pericardial Effusion 354 354
Syncope 342 342
Twiddlers Syndrome 338 338
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 324 324
Asystole 304 304
No Patient Involvement 277 277
Perforation 275 275
Therapeutic Effects, Unexpected 273 273
Fall 269 269
Foreign Body In Patient 264 264
Ventricular Tachycardia 224 224
Obstruction/Occlusion 222 222
Device Overstimulation of Tissue 205 205
Atrial Fibrillation 199 199
Fluid Discharge 191 191
Twiddlers Syndrome 177 177
Low Blood Pressure/ Hypotension 168 168
Failure of Implant 155 155

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Sep-19-2023
2 BIOTRONIK Inc II Apr-21-2021
3 Boston Scientific Corporation II Jan-05-2024
4 Boston Scientific Corporation II Aug-22-2023
5 Boston Scientific Corporation II Mar-03-2023
6 Boston Scientific Corporation II Sep-02-2022
7 Boston Scientific Corporation II Feb-18-2021
8 Boston Scientific Corporation I Feb-05-2021
9 Boston Scientific Corporation I Jan-19-2021
10 Boston Scientific Corporation II Oct-31-2020
11 Boston Scientific Corporation II Mar-03-2020
12 Boston Scientific Corporation II Sep-13-2019
13 Medtronic Inc. II Jun-26-2024
14 Medtronic Inc. II Jan-22-2024
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Jun-16-2023
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Aug-09-2022
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-14-2022
18 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Mar-27-2021
19 St Jude Medical Inc. I Aug-02-2019
20 St. Jude Medical, Cardiac Rhythm Management Division II Apr-21-2022
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