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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	15735	15743
Premature Discharge of Battery	13009	13014
Over-Sensing	5799	5805
Incorrect, Inadequate or Imprecise Result or Readings	5431	5439
Battery Problem	4375	4379
Defective Device	4231	4233
High impedance	3843	3849
Pacing Problem	3672	3674
Signal Artifact/Noise	3457	3464
Failure to Capture	2948	2954
High Capture Threshold	1956	1958
Under-Sensing	1912	1915
Failure to Interrogate	1533	1534
Failure to Read Input Signal	879	880
Interrogation Problem	868	868
Low impedance	805	806
Device Dislodged or Dislocated	733	736
No Pacing	727	727
Incorrect Measurement	615	615
Inappropriate/Inadequate Shock/Stimulation	588	590
Connection Problem	546	547
Pacemaker Found in Back-Up Mode	531	532
No Apparent Adverse Event	502	503
Data Problem	438	438
Material Integrity Problem	434	437
Telemetry Discrepancy	418	418
Impedance Problem	347	350
Noise, Audible	340	340
Insufficient Information	327	327
Device Sensing Problem	309	309
Loose or Intermittent Connection	293	293
Pacing Asynchronously	223	224
Inappropriate or Unexpected Reset	219	220
Capturing Problem	211	212
Off-Label Use	197	197
Pocket Stimulation	197	198
Inaccurate Synchronization	190	190
Use of Device Problem	188	188
Migration	172	172
Failure to Disconnect	163	163
Positioning Problem	140	140
Difficult to Remove	132	132
Fracture	117	117
Unexpected Therapeutic Results	117	119
Communication or Transmission Problem	116	117
Break	108	108
Difficult to Insert	104	104
Output Problem	98	98
Appropriate Term/Code Not Available	97	97
Wireless Communication Problem	86	87

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	42146	42191
Unspecified Infection	6881	6884
Insufficient Information	2978	2979
Syncope/Fainting	1139	1140
Pocket Erosion	983	984
Sepsis	843	843
No Code Available	835	835
Arrhythmia	831	833
Asystole	740	740
Discomfort	677	678
Dizziness	671	672
Device Overstimulation of Tissue	607	608
No Known Impact Or Consequence To Patient	544	544
Bradycardia	513	513
Electric Shock	427	429
Bacterial Infection	317	317
Dyspnea	312	312
Shock from Patient Lead(s)	247	247
Fatigue	242	243
Pain	219	219
No Consequences Or Impact To Patient	201	201
Unspecified Heart Problem	196	197
Hematoma	186	188
Wound Dehiscence	184	184
Fall	180	180
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	151	151
Erosion	142	142
Presyncope	134	134
Swelling/ Edema	121	121
Endocarditis	114	114
Loss of consciousness	111	112
Chest Pain	102	102
Anxiety	86	86
Tachycardia	86	86
Cardiac Arrest	85	85
Atrial Fibrillation	84	84
Undesired Nerve Stimulation	79	79
Ventricular Fibrillation	77	77
Fever	76	76
Malaise	71	71
Purulent Discharge	62	62
Heart Failure/Congestive Heart Failure	60	60
Hypersensitivity/Allergic reaction	55	55
Low Blood Pressure/ Hypotension	51	51
Muscle Weakness	49	49
Twiddlers Syndrome	47	47
Failure of Implant	46	46
Impaired Healing	45	45
Head Injury	42	42
Fluid Discharge	40	40

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