TPLC - Total Product Life Cycle

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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)
2021	2022	2023	2024	2025	2026
70	65	54	58	46	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Discharge of Battery	16486	16491
Adverse Event Without Identified Device or Use Problem	16342	16350
Over-Sensing	6274	6280
Incorrect, Inadequate or Imprecise Result or Readings	6060	6068
Battery Problem	4593	4597
Defective Device	4232	4234
High impedance	4078	4084
Pacing Problem	3949	3951
Signal Artifact/Noise	3724	3731
Failure to Capture	3222	3228
High Capture Threshold	2093	2095
Under-Sensing	2092	2095
Failure to Interrogate	1637	1638
Interrogation Problem	1552	1552
Failure to Read Input Signal	953	954
Low impedance	879	880
No Pacing	763	763
Device Dislodged or Dislocated	761	764
Data Problem	736	736
Incorrect Measurement	632	632
Inappropriate/Inadequate Shock/Stimulation	611	613
No Apparent Adverse Event	604	605
Connection Problem	576	577
Insufficient Information	543	543
Pacemaker Found in Back-Up Mode	531	532
Material Integrity Problem	470	473
Use of Device Problem	443	443
Telemetry Discrepancy	418	418
Impedance Problem	370	373
Noise, Audible	349	349
Device Sensing Problem	334	334
Loose or Intermittent Connection	316	316
Pacing Asynchronously	238	239
Capturing Problem	231	232
Inappropriate or Unexpected Reset	228	229
Off-Label Use	214	214
Pocket Stimulation	207	208
Inaccurate Synchronization	190	190
Migration	189	189
Failure to Disconnect	179	179
Positioning Problem	156	156
Nonstandard Device	154	154
Difficult to Remove	145	145
Communication or Transmission Problem	138	139
Fracture	124	124
Unexpected Therapeutic Results	119	121
Break	113	113
Difficult to Insert	111	111
Output Problem	107	107
Appropriate Term/Code Not Available	99	99

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47853	47898
Unspecified Infection	7323	7326
Insufficient Information	3146	3147
Syncope/Fainting	1222	1223
Pocket Erosion	1049	1050
Arrhythmia	895	897
Sepsis	857	857
No Code Available	835	835
Asystole	798	798
Discomfort	760	761
Dizziness	716	717
Device Overstimulation of Tissue	651	652
Bradycardia	587	587
No Known Impact Or Consequence To Patient	544	544
Electric Shock	428	430
Dyspnea	340	340
Bacterial Infection	332	332
Shock from Patient Lead(s)	271	271
Fatigue	258	259
Pain	236	236
Unspecified Heart Problem	217	218
Wound Dehiscence	209	209
No Consequences Or Impact To Patient	201	201
Hematoma	197	199
Fall	197	197
Erosion	152	152
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	152	152
Presyncope	141	141
Swelling/ Edema	139	139
Loss of consciousness	120	121
Chest Pain	118	118
Endocarditis	115	115
Anxiety	94	94
Atrial Fibrillation	93	93
Tachycardia	92	92
Cardiac Arrest	89	89
Undesired Nerve Stimulation	89	89
Fever	86	86
Malaise	82	82
Ventricular Fibrillation	79	79
Heart Failure/Congestive Heart Failure	69	69
Purulent Discharge	67	67
Hypersensitivity/Allergic reaction	65	65
Low Blood Pressure/ Hypotension	61	61
Twiddlers Syndrome	55	55
Muscle Weakness	55	55
Failure of Implant	50	50
Heart Block	50	50
Impaired Healing	46	46
Fluid Discharge	45	45

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Apr-24-2026
2	Boston Scientific Corporation	I	Oct-10-2025
3	Boston Scientific Corporation	I	Jan-10-2025
4	Boston Scientific Corporation	I	Jul-13-2021
5	Boston Scientific Corporation	II	Jul-02-2021