TPLC - Total Product Life Cycle

• Device: leadless pacemaker
• Regulation Description: Implantable pacemaker pulse generator.
• Definition: To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
• Product Code: PNJ
• Regulation Number: 870.3610
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
37	36	22	28	33	0

MDR Year	MDR Reports	MDR Events
2021	1479	1481
2022	1712	1719
2023	2626	2631
2024	3392	3393
2025	4433	4435
2026	447	447

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Capture Threshold	2468	2469
Adverse Event Without Identified Device or Use Problem	2294	2297
Failure to Capture	1817	1820
Device Dislodged or Dislocated	1643	1645
Capturing Problem	1628	1628
Use of Device Problem	1571	1572
Pacing Problem	1368	1369
Positioning Problem	1277	1277
Stretched	792	792
Appropriate Term/Code Not Available	754	755
Under-Sensing	685	686
Premature Discharge of Battery	558	559
Material Integrity Problem	552	552
Device Sensing Problem	450	451
Mechanical Problem	430	430
Failure to Interrogate	408	408
Low impedance	363	364
Premature Separation	361	361
Activation, Positioning or Separation Problem	344	344
Impedance Problem	343	343
Intermittent Capture	330	330
Leak/Splash	323	323
Separation Failure	313	315
Decreased Sensitivity	311	311
Unstable Capture Threshold	304	304
High impedance	304	305
Connection Problem	246	246
Over-Sensing	242	242
Inappropriate or Unexpected Reset	220	220
Positioning Failure	210	212
Data Problem	153	153
Incorrect Measurement	144	144
Electrical /Electronic Property Problem	130	130
Deformation Due to Compressive Stress	127	127
Interrogation Problem	126	126
Intermittent Communication Failure	110	110
Difficult or Delayed Separation	110	110
Communication or Transmission Problem	103	103
Coagulation in Device or Device Ingredient	90	90
Failure to Sense	89	89
Break	85	85
Insufficient Information	84	84
Incorrect, Inadequate or Imprecise Result or Readings	82	82
Signal Artifact/Noise	78	78
Difficult to Flush	77	77
Difficult or Delayed Positioning	73	73
Material Twisted/Bent	68	68
Reset Problem	59	59
Migration or Expulsion of Device	59	60
Battery Problem	57	57

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8877	8888
Pericardial Effusion	1470	1471
Cardiac Perforation	1269	1269
Cardiac Tamponade	921	921
Arrhythmia	663	664
Low Blood Pressure/ Hypotension	646	646
Embolism/Embolus	614	615
Bradycardia	601	601
Insufficient Information	337	338
Cardiac Arrest	292	292
Dyspnea	290	291
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	240	240
Syncope/Fainting	235	237
Dizziness	235	235
Discomfort	232	232
Unspecified Infection	182	182
Thrombosis/Thrombus	179	179
Tachycardia	157	158
Chest Pain	157	157
Heart Block	126	126
Asystole	122	122
Fatigue	114	114
Hemorrhage/Bleeding	109	109
Heart Failure/Congestive Heart Failure	106	106
Perforation	98	99
Ventricular Fibrillation	75	75
Non specific EKG/ECG Changes	72	72
Tricuspid Valve Insufficiency/ Regurgitation	64	64
Hematoma	57	58
Loss of consciousness	53	54
Atrial Fibrillation	48	48
Pain	47	47
Stroke/CVA	47	47
Sepsis	46	47
Presyncope	38	38
Fall	38	38
Muscle Weakness	38	38
Cardiomyopathy	37	37
High Blood Pressure/ Hypertension	36	36
Valvular Insufficiency/ Regurgitation	35	35
Pulmonary Embolism	34	34
Swelling/ Edema	33	33
Respiratory Failure	33	33
Pleural Effusion	32	32
Fever	30	30
Endocarditis	29	29
Bacterial Infection	29	29
Pericarditis	28	28
Vascular Dissection	25	25
Myocardial Infarction	21	21

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Medical	II	Apr-14-2025
2	Abbott Medical	II	Dec-23-2024
3	Abbott Medical	II	Apr-29-2024