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	15

MDR Year	MDR Reports	MDR Events
2021	1479	1481
2022	1712	1719
2023	2626	2631
2024	3392	3393
2025	4433	4435
2026	2813	2813

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Capture Threshold	2784	2785
Adverse Event Without Identified Device or Use Problem	2622	2625
Failure to Capture	2135	2138
Device Dislodged or Dislocated	1976	1978
Capturing Problem	1896	1896
Use of Device Problem	1818	1819
Pacing Problem	1505	1505
Positioning Problem	1474	1474
Stretched	1024	1024
Appropriate Device Problem Term/Code Not Available	847	848
Under-Sensing	741	742
Premature Discharge of Battery	635	636
Material Integrity Problem	631	631
Device Sensing Problem	517	518
Failure to Interrogate	509	509
Mechanical Problem	505	505
Premature Separation	480	480
Low impedance	442	443
Activation, Positioning or Separation Problem	420	420
Separation Failure	417	419
Impedance Problem	386	386
Intermittent Capture	373	373
High impedance	357	358
Decreased Sensitivity	341	341
Unstable Capture Threshold	330	330
Leak/Splash	330	330
Connection Problem	313	313
Over-Sensing	285	285
Positioning Failure	273	275
Inappropriate or Unexpected Reset	265	265
Data Problem	235	235
Incorrect Measurement	170	170
Interrogation Problem	153	153
Deformation Due to Compressive Stress	147	147
Electrical /Electronic Property Problem	134	134
Difficult or Delayed Separation	126	126
Intermittent Communication Failure	125	125
Failure to Sense	121	121
Communication or Transmission Problem	116	116
Coagulation in Device or Device Ingredient	106	106
Insufficient Device Problem Information	104	104
Break	103	103
Signal Artifact/Noise	92	92
Incorrect, Inadequate or Imprecise Result or Readings	90	90
Material Twisted/Bent	87	87
Difficult or Delayed Positioning	87	87
Difficult to Flush	85	85
Migration or Expulsion of Device	70	70
Battery Problem	65	65
Reset Problem	63	63

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10399	10410
Pericardial Effusion	1743	1744
Cardiac Perforation	1501	1501
Cardiac Tamponade	1106	1106
Embolism/Embolus	815	816
Arrhythmia	807	808
Low Blood Pressure/ Hypotension	774	774
Bradycardia	650	650
Insufficient Information	379	380
Dyspnea	325	326
Cardiac Arrest	311	311
Discomfort	286	286
Syncope/Fainting	272	274
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	263	263
Dizziness	260	260
Unspecified Infection	218	218
Thrombosis/Thrombus	207	207
Chest Pain	166	166
Tachycardia	163	164
Asystole	137	137
Heart Block	133	133
Heart Failure/Congestive Heart Failure	131	131
Fatigue	128	128
Hemorrhage/Blood Loss/Bleeding	126	126
Perforation	100	101
Non specific EKG/ECG Changes	79	79
Ventricular Fibrillation	78	78
Tricuspid Valve Insufficiency/ Regurgitation	75	75
Hematoma	63	64
Loss of consciousness	61	62
Atrial Fibrillation	54	54
Pain	52	52
Stroke/CVA	51	51
Sepsis	50	51
Valvular Insufficiency/ Regurgitation	49	49
Cardiomyopathy	47	47
Fall	41	41
Muscle Weakness/Atrophy	41	41
Presyncope	41	41
Fever	39	39
Respiratory Failure	39	39
High Blood Pressure/ Hypertension	38	38
Pulmonary Embolism	37	37
Swelling/ Edema	34	34
Pleural Effusion	33	33
Endocarditis	33	33
Pericarditis	29	29
Bacterial Infection	29	29
Vascular Dissection	26	26
Unspecified Tissue Injury	24	24

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Medical	II	Jun-11-2026
2	Abbott Medical	II	Apr-14-2025
3	Abbott Medical	II	Dec-23-2024
4	Abbott Medical	II	Apr-29-2024