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)
2020	2021	2022	2023	2024	2025
30	26	24	27	23	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1656	1656
Incorrect, Inadequate or Imprecise Result or Readings	1172	1172
Premature Discharge of Battery	913	913
Over-Sensing	767	767
Pacing Problem	751	751
High impedance	413	413
Signal Artifact/Noise	393	393
Failure to Capture	270	270
Defective Device	248	248
Battery Problem	194	194
Appropriate Term/Code Not Available	172	172
Low impedance	164	164
Unable to Obtain Readings	152	152
Under-Sensing	121	121
High Capture Threshold	119	119
Mechanical Problem	107	107
Failure to Interrogate	91	91
Inappropriate or Unexpected Reset	90	90
Interrogation Problem	81	81
False Alarm	73	73
Impedance Problem	68	68
Failure to Read Input Signal	65	65
Connection Problem	62	62
Incorrect Measurement	62	62
Off-Label Use	56	56
Data Problem	56	56
Loose or Intermittent Connection	53	53
Capturing Problem	46	46
Pocket Stimulation	45	45
Pacemaker Found in Back-Up Mode	43	43
Telemetry Discrepancy	43	43
Device Sensing Problem	41	41
Insufficient Information	40	40
Migration or Expulsion of Device	37	37
Electromagnetic Interference	34	34
Communication or Transmission Problem	29	29
Premature Elective Replacement Indicator	28	28
No Pacing	28	28
Misconnection	27	27
Use of Device Problem	26	26
Reset Problem	22	22
False Positive Result	20	20
Migration	16	16
Therapy Delivered to Incorrect Body Area	14	14
Unexpected Therapeutic Results	14	14
Wireless Communication Problem	12	12
Inaccurate Synchronization	11	11
Failure to Disconnect	9	9
Electrical /Electronic Property Problem	9	9
Intermittent Capture	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3318	3318
Unspecified Infection	1290	1290
No Known Impact Or Consequence To Patient	263	263
Insufficient Information	231	231
Syncope/Fainting	209	209
No Code Available	191	191
Device Overstimulation of Tissue	185	185
Pocket Erosion	174	174
Bradycardia	171	171
Sepsis	154	154
No Consequences Or Impact To Patient	144	144
Asystole	135	135
Discomfort	121	121
Dizziness	110	110
Hematoma	78	78
Pain	71	71
Dyspnea	68	68
Bacterial Infection	68	68
Erosion	66	66
Arrhythmia	54	54
Erythema	47	47
Fall	47	47
Presyncope	42	42
Wound Dehiscence	41	41
Swelling/ Edema	41	41
Purulent Discharge	41	41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
Chest Pain	37	37
Fatigue	36	36
Fever	35	35
Endocarditis	32	32
Tachycardia	28	28
Undesired Nerve Stimulation	25	25
Cardiac Arrest	25	25
Unspecified Heart Problem	24	24
Syncope	22	22
Loss of consciousness	21	21
Drug Resistant Bacterial Infection	20	20
Atrial Fibrillation	17	17
Heart Failure/Congestive Heart Failure	17	17
Muscle Stimulation	16	16
Fluid Discharge	15	15
Failure of Implant	14	14
Death	14	14
Malaise	13	13
Non specific EKG/ECG Changes	11	11
Head Injury	11	11
Anxiety	11	11
Hemorrhage/Bleeding	10	10
Muscle Weakness	10	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Jan-10-2025
2	Boston Scientific Corporation	I	Jul-13-2021
3	Boston Scientific Corporation	II	Jul-02-2021
4	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Apr-30-2021