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)
2019	2020	2021	2022	2023	2024
88	90	70	65	54	31

MDR Year	MDR Reports	MDR Events
2019	9627	9627
2020	8989	8989
2021	9374	9374
2022	14287	14287
2023	12639	12639
2024	7069	7069

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16352	16352
Premature Discharge of Battery	16004	16004
Over-Sensing	5221	5221
High impedance	4469	4469
Battery Problem	4077	4077
Defective Device	3836	3836
Pacing Problem	3392	3392
Incorrect, Inadequate or Imprecise Result or Readings	3357	3357
Device Displays Incorrect Message	3246	3246
Signal Artifact/Noise	3007	3007
Failure to Capture	2596	2596
High Capture Threshold	1965	1965
Under-Sensing	1404	1404
Failure to Interrogate	1320	1320
Noise, Audible	1153	1153
Pacemaker Found in Back-Up Mode	953	953
Device Sensing Problem	921	921
Device Dislodged or Dislocated	890	890
Low impedance	859	859
No Pacing	646	646
Inappropriate/Inadequate Shock/Stimulation	643	643
Connection Problem	642	642
Incorrect Measurement	605	605
Material Integrity Problem	588	588
Interrogation Problem	579	579
Failure to Read Input Signal	524	524
Impedance Problem	454	454
Data Problem	453	453
No Apparent Adverse Event	402	402
Telemetry Discrepancy	295	295
Inappropriate or Unexpected Reset	281	281
Pocket Stimulation	278	278
Loose or Intermittent Connection	252	252
Off-Label Use	246	246
Migration	224	224
Insufficient Information	210	210
Use of Device Problem	202	202
Inaccurate Synchronization	187	187
Capturing Problem	187	187
Appropriate Term/Code Not Available	175	175
Pacing Asynchronously	175	175
Difficult to Insert	173	173
Positioning Problem	167	167
Unexpected Therapeutic Results	163	163
Output Problem	159	159
Mechanical Problem	143	143
Communication or Transmission Problem	140	140
Failure to Disconnect	124	124
Difficult to Remove	123	123
Reset Problem	121	121

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	31865	31865
No Known Impact Or Consequence To Patient	9128	9128
Unspecified Infection	7630	7630
No Code Available	4384	4384
No Consequences Or Impact To Patient	3344	3344
Insufficient Information	2521	2521
Sepsis	1567	1567
Pocket Erosion	1084	1084
Syncope/Fainting	847	847
Arrhythmia	649	649
Dizziness	606	606
Discomfort	556	556
Asystole	542	542
Electric Shock	536	536
Device Overstimulation of Tissue	438	438
No Patient Involvement	423	423
Bradycardia	418	418
Syncope	362	362
Bacterial Infection	326	326
Dyspnea	261	261
Fatigue	224	224
Pain	218	218
Muscle Stimulation	216	216
Death	210	210
No Information	198	198
Hematoma	197	197
Atrial Fibrillation	191	191
Erosion	191	191
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	163	163
Wound Dehiscence	153	153
Fall	141	141
Endocarditis	141	141
Unspecified Heart Problem	111	111
Cardiac Arrest	107	107
Chest Pain	99	99
Ventricular Fibrillation	99	99
Shock from Patient Lead(s)	98	98
Undesired Nerve Stimulation	92	92
Presyncope	88	88
Anxiety	84	84
Swelling/ Edema	82	82
Tachycardia	71	71
Fever	71	71
Purulent Discharge	65	65
Loss of consciousness	62	62
Staphylococcus Aureus	60	60
Hypersensitivity/Allergic reaction	57	57
Malaise	52	52
Low Blood Pressure/ Hypotension	48	48
Twiddlers Syndrome	48	48

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