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)
2021	2022	2023	2024	2025	2026
26	24	27	23	22	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Premature Discharge of Battery	2359	2361
Adverse Event Without Identified Device or Use Problem	1880	1881
Incorrect, Inadequate or Imprecise Result or Readings	1541	1543
Pacing Problem	971	971
Over-Sensing	961	961
Signal Artifact/Noise	495	495
High impedance	447	449
Interrogation Problem	377	377
Failure to Capture	377	379
Defective Device	305	305
Battery Problem	283	283
Appropriate Device Problem Term/Code Not Available	220	220
Data Problem	187	187
Under-Sensing	179	179
Low impedance	165	167
High Capture Threshold	164	165
Use of Device Problem	152	152
Mechanical Problem	133	134
False Alarm	121	121
Failure to Read Input Signal	103	103
Failure to Interrogate	97	98
Telemetry Discrepancy	87	87
Inappropriate or Unexpected Reset	84	84
Insufficient Device Problem Information	84	84
Unable to Obtain Readings	78	78
Loose or Intermittent Connection	75	75
Impedance Problem	71	72
Connection Problem	65	66
Incorrect Measurement	60	61
Device Sensing Problem	54	54
Off-Label Use	53	53
Extracardiac stimulation	50	50
Capturing Problem	49	49
Electromagnetic Interference	48	48
Migration or Expulsion of Device	42	42
Communication or Transmission Problem	39	39
Pacemaker Found in Back-Up Mode	35	35
Nonstandard Device	35	35
No Pacing	33	33
No Apparent Adverse Event	32	32
Premature Elective Replacement Indicator	31	31
Misconnection	29	29
Unexpected Mode Switch	22	22
Reset Problem	22	22
Failure to Disconnect	20	20
False Positive Result	19	19
Migration	18	18
Unexpected Therapeutic Results	17	17
Inaccurate Synchronization	14	14
Therapy Delivered to Incorrect Body Area	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5972	5982
Unspecified Infection	1411	1411
Insufficient Information	287	287
Syncope/Fainting	269	269
Device Overstimulation of Tissue	240	240
Bradycardia	224	224
Pocket Erosion	189	189
Asystole	181	181
Discomfort	157	157
Dizziness	138	138
Sepsis	129	129
Pain	102	102
Erosion	98	98
Bacterial Infection	92	92
Dyspnea	88	88
Hematoma	86	86
Erythema	76	76
Bacteremia	74	74
Swelling/ Edema	73	73
Arrhythmia	73	73
No Code Available	64	64
Fall	62	62
Purulent Discharge	61	61
Wound Dehiscence	57	57
Presyncope	52	52
Medical device site infection	48	48
Chest Pain	48	48
Fever	47	47
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	46	46
Fatigue	44	44
Tachycardia	42	42
Unspecified Heart Problem	39	39
Cardiac Arrest	35	35
Endocarditis	34	34
Loss of consciousness	33	33
Drug Resistant Bacterial Infection	29	29
Heart Failure/Congestive Heart Failure	29	29
No Known Impact Or Consequence To Patient	27	27
Undesired Nerve Stimulation	25	25
Atrial Fibrillation	18	18
Failure of Implant	17	17
Muscle Weakness/Atrophy	17	17
Malaise	16	16
Fluid Discharge	15	15
Anxiety	14	14
Head Injury	13	13
Non specific EKG/ECG Changes	13	13
Palpitations	12	12
Hemorrhage/Blood Loss/Bleeding	11	11
Hypersensitivity/Allergic reaction	11	11

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