TPLC - Total Product Life Cycle

show TPLC since

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)
2020	2021	2022	2023	2024	2025
30	26	24	27	23	18

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1893	1893
Incorrect, Inadequate or Imprecise Result or Readings	1386	1386
Premature Discharge of Battery	1158	1158
Over-Sensing	914	914
Pacing Problem	878	878
Signal Artifact/Noise	473	473
High impedance	471	471
Failure to Capture	320	320
Defective Device	317	317
Battery Problem	226	226
Appropriate Term/Code Not Available	207	207
Low impedance	177	177
Unable to Obtain Readings	155	155
Under-Sensing	151	151
High Capture Threshold	148	148
Mechanical Problem	132	132
Failure to Interrogate	104	104
False Alarm	98	98
Interrogation Problem	97	97
Inappropriate or Unexpected Reset	92	92
Data Problem	90	90
Failure to Read Input Signal	81	81
Telemetry Discrepancy	77	77
Impedance Problem	77	77
Incorrect Measurement	68	68
Connection Problem	67	67
Loose or Intermittent Connection	66	66
Off-Label Use	62	62
Pocket Stimulation	52	52
Capturing Problem	51	51
Insufficient Information	47	47
Device Sensing Problem	45	45
Migration or Expulsion of Device	45	45
Pacemaker Found in Back-Up Mode	43	43
Electromagnetic Interference	39	39
Communication or Transmission Problem	35	35
Use of Device Problem	34	34
Premature Elective Replacement Indicator	31	31
No Pacing	30	30
Misconnection	29	29
Reset Problem	24	24
Migration	21	21
False Positive Result	20	20
Unexpected Therapeutic Results	16	16
Wireless Communication Problem	14	14
Inaccurate Synchronization	14	14
Therapy Delivered to Incorrect Body Area	14	14
Electrical /Electronic Property Problem	13	13
No Apparent Adverse Event	13	13
Failure to Disconnect	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4085	4085
Unspecified Infection	1454	1454
Insufficient Information	269	269
No Known Impact Or Consequence To Patient	263	263
Syncope/Fainting	243	243
Device Overstimulation of Tissue	217	217
Bradycardia	201	201
Pocket Erosion	200	200
No Code Available	191	191
Sepsis	165	165
Asystole	161	161
No Consequences Or Impact To Patient	144	144
Discomfort	143	143
Dizziness	130	130
Bacterial Infection	89	89
Hematoma	88	88
Pain	86	86
Erosion	85	85
Dyspnea	78	78
Arrhythmia	65	65
Erythema	64	64
Swelling/ Edema	55	55
Purulent Discharge	53	53
Fall	51	51
Wound Dehiscence	49	49
Presyncope	47	47
Fever	46	46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	44
Chest Pain	40	40
Fatigue	40	40
Endocarditis	37	37
Tachycardia	32	32
Unspecified Heart Problem	32	32
Loss of consciousness	27	27
Cardiac Arrest	27	27
Undesired Nerve Stimulation	26	26
Drug Resistant Bacterial Infection	26	26
Syncope	22	22
Heart Failure/Congestive Heart Failure	20	20
Atrial Fibrillation	18	18
Malaise	17	17
Muscle Stimulation	16	16
Fluid Discharge	15	15
Failure of Implant	15	15
Death	14	14
Anxiety	13	13
Muscle Weakness	12	12
Head Injury	11	11
Non specific EKG/ECG Changes	11	11
Hemorrhage/Bleeding	10	10

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