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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device leadless pacemaker
Definition To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Product CodePNJ
Regulation Number 870.3610
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
15 27 37 36 22 15

MDR Year MDR Reports MDR Events
2019 837 837
2020 1147 1147
2021 1479 1479
2022 1712 1712
2023 2627 2627
2024 2083 2083

Device Problems MDRs with this Device Problem Events in those MDRs
High Capture Threshold 2044 2044
Adverse Event Without Identified Device or Use Problem 1649 1649
Failure to Capture 1159 1159
Pacing Problem 1148 1148
Capturing Problem 1122 1122
Positioning Problem 1059 1059
Use of Device Problem 1018 1018
Device Dislodged or Dislocated 957 957
Appropriate Term/Code Not Available 646 646
Under-Sensing 603 603
Material Integrity Problem 452 452
Premature Discharge of Battery 444 444
Device Sensing Problem 330 330
Mechanical Problem 324 324
Decreased Sensitivity 292 292
Stretched 265 265
Unstable Capture Threshold 243 243
High impedance 240 240
Failure to Interrogate 229 229
Leak/Splash 227 227
Intermittent Capture 217 217
Impedance Problem 214 214
Activation, Positioning or Separation Problem 193 193
Premature Separation 166 166
Over-Sensing 150 150
Inappropriate or Unexpected Reset 134 134
Low impedance 128 128
Electrical /Electronic Property Problem 122 122
Deformation Due to Compressive Stress 91 91
Separation Failure 80 80
Communication or Transmission Problem 79 79
Connection Problem 76 76
Incorrect Measurement 71 71
Reset Problem 69 69
Coagulation in Device or Device Ingredient 64 64
Positioning Failure 59 59
Incorrect, Inadequate or Imprecise Result or Readings 56 56
Interrogation Problem 55 55
Intermittent Communication Failure 54 54
Failure to Advance 54 54
Insufficient Information 52 52
Signal Artifact/Noise 49 49
Difficult to Flush 47 47
Output Problem 46 46
Battery Problem 43 43
Migration or Expulsion of Device 43 43
Difficult or Delayed Positioning 41 41
Difficult or Delayed Separation 40 40
Break 36 36
Material Twisted/Bent 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5140 5140
Pericardial Effusion 997 997
Cardiac Perforation 869 869
No Known Impact Or Consequence To Patient 778 778
Cardiac Tamponade 686 686
Bradycardia 490 490
Low Blood Pressure/ Hypotension 401 401
No Consequences Or Impact To Patient 341 341
Arrhythmia 325 325
Cardiac Arrest 258 258
Dyspnea 213 213
Insufficient Information 175 175
Dizziness 170 170
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 164 164
Syncope/Fainting 158 158
Unspecified Infection 148 148
Chest Pain 144 144
Embolism/Embolus 128 128
Tachycardia 127 127
Death 125 125
Heart Block 106 106
Discomfort 106 106
Perforation 106 106
Thrombosis/Thrombus 91 91
Hemorrhage/Bleeding 75 75
Asystole 75 75
Fatigue 75 75
Heart Failure/Congestive Heart Failure 71 71
Ventricular Fibrillation 62 62
Non specific EKG/ECG Changes 55 55
Pain 53 53
Hematoma 48 48
Sepsis 46 46
Pleural Effusion 39 39
Tricuspid Valve Insufficiency/ Regurgitation 39 39
Loss of consciousness 38 38
Fall 35 35
Atrial Fibrillation 34 34
Cardiomyopathy 34 34
No Code Available 33 33
Fever 33 33
Endocarditis 31 31
Syncope 30 30
Stroke/CVA 30 30
Muscle Weakness 29 29
Swelling/ Edema 25 25
Pulmonary Embolism 22 22
Pseudoaneurysm 22 22
High Blood Pressure/ Hypertension 21 21
Ventricular Tachycardia 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Apr-29-2024
2 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Sep-09-2019
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