TPLC - Total Product Life Cycle

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Device	pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Definition	These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.
Product Code	NKE
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
26	24	27	23	22	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Discharge of Battery	1894	1895
Adverse Event Without Identified Device or Use Problem	1801	1802
Incorrect, Inadequate or Imprecise Result or Readings	1502	1504
Pacing Problem	923	923
Over-Sensing	910	910
Signal Artifact/Noise	465	465
High impedance	424	426
Failure to Capture	356	358
Interrogation Problem	309	309
Defective Device	307	307
Battery Problem	276	276
Appropriate Term/Code Not Available	204	204
Under-Sensing	164	164
Data Problem	163	163
Low impedance	162	164
High Capture Threshold	159	160
Mechanical Problem	126	127
False Alarm	112	112
Failure to Interrogate	95	96
Failure to Read Input Signal	93	93
Use of Device Problem	92	92
Telemetry Discrepancy	87	87
Inappropriate or Unexpected Reset	83	83
Unable to Obtain Readings	78	78
Insufficient Information	73	73
Impedance Problem	72	73
Loose or Intermittent Connection	71	71
Connection Problem	62	63
Incorrect Measurement	59	60
Pocket Stimulation	48	48
Off-Label Use	48	48
Capturing Problem	47	47
Electromagnetic Interference	44	44
Device Sensing Problem	44	44
Migration or Expulsion of Device	40	40
Pacemaker Found in Back-Up Mode	37	37
Communication or Transmission Problem	36	36
Nonstandard Device	35	35
No Pacing	30	30
Premature Elective Replacement Indicator	29	29
Misconnection	27	27
No Apparent Adverse Event	26	26
Reset Problem	22	22
Failure to Disconnect	18	18
Unexpected Therapeutic Results	17	17
Migration	17	17
False Positive Result	16	16
Therapy Delivered to Incorrect Body Area	14	14
Inaccurate Synchronization	14	14
Wireless Communication Problem	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5306	5315
Unspecified Infection	1354	1354
Insufficient Information	277	277
Syncope/Fainting	259	259
Device Overstimulation of Tissue	233	233
Bradycardia	212	212
Pocket Erosion	183	183
Asystole	173	173
Discomfort	151	151
Dizziness	133	133
Sepsis	126	126
Pain	96	96
Erosion	94	94
Bacterial Infection	90	90
Dyspnea	82	82
Hematoma	78	78
Erythema	73	73
Arrhythmia	70	70
Swelling/ Edema	66	66
No Code Available	64	64
Purulent Discharge	59	59
Fall	56	56
Wound Dehiscence	54	54
Presyncope	52	52
Chest Pain	46	46
Fever	44	44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Tachycardia	41	41
Fatigue	41	41
Unspecified Heart Problem	39	39
Endocarditis	32	32
Cardiac Arrest	32	32
Loss of consciousness	32	32
No Known Impact Or Consequence To Patient	27	27
Drug Resistant Bacterial Infection	27	27
Heart Failure/Congestive Heart Failure	25	25
Undesired Nerve Stimulation	25	25
Atrial Fibrillation	18	18
Failure of Implant	17	17
Malaise	16	16
Fluid Discharge	15	15
Muscle Weakness	15	15
Non specific EKG/ECG Changes	13	13
Anxiety	13	13
Head Injury	12	12
Hemorrhage/Bleeding	11	11
Heart Block	10	10
Ventricular Fibrillation	10	10
Low Blood Pressure/ Hypotension	10	10
Pericardial Effusion	9	9

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
6	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Apr-30-2021