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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 65

MDR Year MDR Reports MDR Events
2019 16186 16186
2020 16910 16910
2021 19659 19659
2022 23463 23463
2023 28725 28725
2024 17046 17046

Device Problems MDRs with this Device Problem Events in those MDRs
Over-Sensing 29139 29139
High impedance 19315 19315
Adverse Event Without Identified Device or Use Problem 18806 18806
Premature Discharge of Battery 16785 16785
Inappropriate/Inadequate Shock/Stimulation 16762 16762
Signal Artifact/Noise 14827 14827
Fracture 8698 8698
Impedance Problem 6837 6837
High Capture Threshold 6718 6718
Device Sensing Problem 6352 6352
Incorrect, Inadequate or Imprecise Result or Readings 5984 5984
Battery Problem 5325 5325
Failure to Read Input Signal 4691 4691
Under-Sensing 4684 4684
Pacing Problem 4519 4519
Low impedance 3679 3679
Device Dislodged or Dislocated 2923 2923
Failure to Capture 2694 2694
Defective Device 2494 2494
Decreased Sensitivity 2276 2276
Premature Elective Replacement Indicator 2223 2223
Capturing Problem 1873 1873
Noise, Audible 1487 1487
Appropriate Term/Code Not Available 1217 1217
Failure to Convert Rhythm 1212 1212
Break 1156 1156
Inappropriate or Unexpected Reset 1129 1129
Mechanical Problem 1109 1109
Electromagnetic Interference 994 994
Data Problem 958 958
Material Integrity Problem 918 918
Electrical /Electronic Property Problem 907 907
Failure to Interrogate 823 823
Connection Problem 808 808
Failure to Deliver Shock/Stimulation 673 673
Defibrillation/Stimulation Problem 664 664
Interrogation Problem 638 638
Positioning Problem 635 635
Inaccurate Synchronization 634 634
Premature End-of-Life Indicator 600 600
Insufficient Information 600 600
Unstable Capture Threshold 557 557
Migration 549 549
No Apparent Adverse Event 543 543
Positioning Failure 537 537
Activation, Positioning or Separation Problem 520 520
Unexpected Therapeutic Results 428 428
Delayed Charge Time 407 407
Failure to Charge 373 373
Nonstandard Device 364 364

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57330 57330
Unspecified Infection 15195 15195
No Known Impact Or Consequence To Patient 15071 15071
Electric Shock 7915 7915
Shock from Patient Lead(s) 7606 7606
No Consequences Or Impact To Patient 5410 5410
Insufficient Information 3676 3676
No Code Available 3469 3469
Sepsis 2161 2161
Pocket Erosion 1242 1242
Discomfort 909 909
Arrhythmia 872 872
Ventricular Fibrillation 867 867
Syncope/Fainting 858 858
Pain 854 854
Erosion 713 713
Bacterial Infection 675 675
Bradycardia 662 662
Tachycardia 650 650
Dizziness 650 650
Chest Pain 535 535
Hematoma 535 535
Endocarditis 504 504
Dyspnea 476 476
Cardiac Perforation 444 444
Death 443 443
Wound Dehiscence 436 436
Cardiac Arrest 429 429
Swelling/ Edema 390 390
Purulent Discharge 357 357
Pericardial Effusion 344 344
Syncope 342 342
Twiddlers Syndrome 321 321
Fever 310 310
Erythema 309 309
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 307 307
Asystole 284 284
No Patient Involvement 277 277
Therapeutic Effects, Unexpected 273 273
Perforation 272 272
Foreign Body In Patient 263 263
Fall 253 253
Ventricular Tachycardia 224 224
Obstruction/Occlusion 215 215
Device Overstimulation of Tissue 197 197
Atrial Fibrillation 190 190
Fluid Discharge 183 183
Twiddlers Syndrome 177 177
Low Blood Pressure/ Hypotension 155 155
Cardiac Tamponade 149 149

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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