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)
2019	2020	2021	2022	2023	2024
29	30	26	24	27	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1747	1747
Incorrect, Inadequate or Imprecise Result or Readings	1018	1018
Premature Discharge of Battery	905	905
Over-Sensing	764	764
Pacing Problem	699	699
High impedance	452	452
Signal Artifact/Noise	361	361
Failure to Capture	247	247
Defective Device	215	215
Unable to Obtain Readings	190	190
Low impedance	180	180
Battery Problem	172	172
Appropriate Term/Code Not Available	161	161
Inappropriate or Unexpected Reset	122	122
High Capture Threshold	114	114
Mechanical Problem	113	113
Under-Sensing	109	109
Failure to Interrogate	95	95
Impedance Problem	83	83
Device Sensing Problem	82	82
Incorrect Measurement	72	72
Interrogation Problem	71	71
Off-Label Use	66	66
Data Problem	64	64
False Alarm	62	62
Pacemaker Found in Back-Up Mode	58	58
Connection Problem	57	57
Failure to Read Input Signal	54	54
Loose or Intermittent Connection	47	47
Pocket Stimulation	44	44
Capturing Problem	43	43
Reset Problem	43	43
Misconnection	39	39
Telemetry Discrepancy	39	39
Electromagnetic Interference	34	34
Device Displays Incorrect Message	33	33
Insufficient Information	33	33
Migration or Expulsion of Device	33	33
No Pacing	32	32
Communication or Transmission Problem	31	31
Premature Elective Replacement Indicator	31	31
Use of Device Problem	25	25
False Positive Result	20	20
Wireless Communication Problem	17	17
Migration	16	16
Unexpected Therapeutic Results	13	13
Therapy Delivered to Incorrect Body Area	12	12
Intermittent Capture	10	10
Missing Test Results	10	10
Difficult to Insert	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2892	2892
Unspecified Infection	1366	1366
No Known Impact Or Consequence To Patient	665	665
Insufficient Information	213	213
No Code Available	195	195
Pocket Erosion	186	186
No Consequences Or Impact To Patient	179	179
Sepsis	178	178
Syncope/Fainting	177	177
Device Overstimulation of Tissue	158	158
Bradycardia	148	148
Asystole	121	121
Discomfort	110	110
Dizziness	109	109
Hematoma	88	88
Pain	66	66
Erosion	61	61
Dyspnea	59	59
Bacterial Infection	58	58
Syncope	42	42
Fall	41	41
Arrhythmia	40	40
Endocarditis	38	38
Presyncope	37	37
Wound Dehiscence	36	36
Death	36	36
Erythema	35	35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Fatigue	34	34
Purulent Discharge	33	33
Chest Pain	31	31
Swelling/ Edema	31	31
Fever	26	26
Cardiac Arrest	26	26
Undesired Nerve Stimulation	24	24
Tachycardia	23	23
Muscle Stimulation	23	23
Unspecified Heart Problem	22	22
No Patient Involvement	19	19
Atrial Fibrillation	18	18
Heart Failure/Congestive Heart Failure	15	15
Drug Resistant Bacterial Infection	14	14
Loss of consciousness	14	14
Non specific EKG/ECG Changes	13	13
Failure of Implant	13	13
Malaise	12	12
Fluid Discharge	12	12
Head Injury	11	11
Pericardial Effusion	10	10
Septic Shock	10	10

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