TPLC - Total Product Life Cycle

• Device: implantable pulse generator, pacemaker (non-crt)
• Definition: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
• Product Code: LWP
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
90	70	65	54	58	13

MDR Year	MDR Reports	MDR Events
2020	8989	8989
2021	9374	9374
2022	14287	14287
2023	12638	12638
2024	10500	10501
2025	2601	2601

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15894	15895
Premature Discharge of Battery	13881	13881
Over-Sensing	5431	5431
Battery Problem	4378	4378
Incorrect, Inadequate or Imprecise Result or Readings	4232	4232
Defective Device	3975	3975
High impedance	3929	3929
Pacing Problem	3527	3527
Signal Artifact/Noise	3286	3286
Failure to Capture	2677	2677
High Capture Threshold	1902	1902
Under-Sensing	1614	1614
Failure to Interrogate	1388	1388
Low impedance	801	801
Device Dislodged or Dislocated	791	791
Noise, Audible	691	691
Failure to Read Input Signal	679	679
Inappropriate/Inadequate Shock/Stimulation	669	669
No Pacing	659	659
Incorrect Measurement	622	622
Device Displays Incorrect Message	612	612
Pacemaker Found in Back-Up Mode	610	610
Interrogation Problem	607	607
Connection Problem	577	577
Material Integrity Problem	522	522
No Apparent Adverse Event	418	418
Device Sensing Problem	393	393
Data Problem	391	391
Impedance Problem	361	361
Telemetry Discrepancy	327	327
Loose or Intermittent Connection	284	284
Off-Label Use	231	231
Pocket Stimulation	229	229
Inappropriate or Unexpected Reset	219	219
Insufficient Information	213	213
Inaccurate Synchronization	205	205
Migration	202	202
Pacing Asynchronously	199	199
Capturing Problem	188	188
Use of Device Problem	180	180
Positioning Problem	157	157
Difficult to Insert	140	140
Failure to Disconnect	135	135
Appropriate Term/Code Not Available	134	134
Unexpected Therapeutic Results	128	128
Fracture	119	119
Difficult to Remove	118	118
Mechanical Problem	113	113
Output Problem	112	112
Communication or Transmission Problem	108	108

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35893	35893
Unspecified Infection	7189	7190
No Code Available	4264	4264
No Known Impact Or Consequence To Patient	3751	3751
Insufficient Information	2696	2696
No Consequences Or Impact To Patient	1653	1653
Sepsis	1218	1218
Pocket Erosion	1005	1005
Syncope/Fainting	990	990
Arrhythmia	740	740
Asystole	645	645
Dizziness	606	606
Discomfort	603	603
Electric Shock	537	537
Device Overstimulation of Tissue	520	520
Bradycardia	447	447
Bacterial Infection	321	321
Dyspnea	282	282
Fatigue	226	226
Pain	207	207
Hematoma	195	195
Shock from Patient Lead(s)	188	188
No Patient Involvement	184	184
Erosion	174	174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	166	166
Wound Dehiscence	160	160
Fall	157	157
Unspecified Heart Problem	152	152
Syncope	133	133
Endocarditis	129	129
Atrial Fibrillation	128	128
Muscle Stimulation	116	116
Presyncope	113	113
Swelling/ Edema	105	105
Death	100	100
Chest Pain	95	95
No Information	93	93
Cardiac Arrest	89	89
Undesired Nerve Stimulation	88	88
Anxiety	87	87
Ventricular Fibrillation	87	87
Loss of consciousness	87	87
Tachycardia	78	78
Fever	72	72
Purulent Discharge	64	64
Malaise	58	58
Hypersensitivity/Allergic reaction	54	54
Heart Failure/Congestive Heart Failure	52	52
Twiddlers Syndrome	46	46
Low Blood Pressure/ Hypotension	46	46

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Jan-10-2025
2	Boston Scientific Corporation	I	Jul-13-2021
3	Boston Scientific Corporation	II	Jul-02-2021