TPLC - Total Product Life Cycle

• Device: leadless pacemaker
• 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)
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
Material Twisted/Bent	36	36
Break	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
Perforation	106	106
Heart Block	106	106
Discomfort	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
Tricuspid Valve Insufficiency/ Regurgitation	39	39
Pleural Effusion	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
Stroke/CVA	30	30
Syncope	30	30
Muscle Weakness	29	29
Swelling/ Edema	25	25
Pulmonary Embolism	22	22
Pseudoaneurysm	22	22
Ventricular Tachycardia	21	21
High Blood Pressure/ Hypertension	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