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	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1754	1754
Incorrect, Inadequate or Imprecise Result or Readings	1237	1237
Premature Discharge of Battery	981	981
Over-Sensing	817	817
Pacing Problem	797	797
High impedance	435	435
Signal Artifact/Noise	423	423
Failure to Capture	292	292
Defective Device	276	276
Battery Problem	206	206
Appropriate Term/Code Not Available	184	184
Low impedance	170	170
Unable to Obtain Readings	152	152
Under-Sensing	139	139
High Capture Threshold	127	127
Mechanical Problem	112	112
Failure to Interrogate	98	98
Inappropriate or Unexpected Reset	91	91
Interrogation Problem	91	91
False Alarm	83	83
Failure to Read Input Signal	74	74
Impedance Problem	71	71
Connection Problem	65	65
Incorrect Measurement	65	65
Data Problem	62	62
Off-Label Use	59	59
Loose or Intermittent Connection	59	59
Pocket Stimulation	48	48
Capturing Problem	47	47
Telemetry Discrepancy	47	47
Device Sensing Problem	44	44
Pacemaker Found in Back-Up Mode	43	43
Migration or Expulsion of Device	42	42
Insufficient Information	41	41
Electromagnetic Interference	36	36
Premature Elective Replacement Indicator	31	31
Communication or Transmission Problem	30	30
No Pacing	30	30
Use of Device Problem	28	28
Misconnection	27	27
Reset Problem	23	23
False Positive Result	20	20
Migration	18	18
Unexpected Therapeutic Results	14	14
Therapy Delivered to Incorrect Body Area	14	14
Inaccurate Synchronization	13	13
Failure to Disconnect	12	12
Wireless Communication Problem	12	12
Electrical /Electronic Property Problem	11	11
Intermittent Capture	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3581	3581
Unspecified Infection	1356	1356
No Known Impact Or Consequence To Patient	263	263
Insufficient Information	242	242
Syncope/Fainting	222	222
Device Overstimulation of Tissue	196	196
No Code Available	191	191
Pocket Erosion	186	186
Bradycardia	184	184
Sepsis	159	159
No Consequences Or Impact To Patient	144	144
Asystole	144	144
Discomfort	134	134
Dizziness	119	119
Hematoma	83	83
Pain	80	80
Bacterial Infection	78	78
Erosion	73	73
Dyspnea	73	73
Arrhythmia	61	61
Erythema	59	59
Swelling/ Edema	49	49
Fall	48	48
Purulent Discharge	48	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
Wound Dehiscence	43	43
Presyncope	42	42
Fever	39	39
Fatigue	38	38
Chest Pain	38	38
Endocarditis	33	33
Tachycardia	29	29
Unspecified Heart Problem	28	28
Cardiac Arrest	26	26
Undesired Nerve Stimulation	26	26
Loss of consciousness	23	23
Syncope	22	22
Drug Resistant Bacterial Infection	21	21
Heart Failure/Congestive Heart Failure	19	19
Atrial Fibrillation	18	18
Muscle Stimulation	16	16
Fluid Discharge	15	15
Death	14	14
Failure of Implant	14	14
Malaise	14	14
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