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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
22	27	29	19	44	54	58	33	48	29	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	2484	2484
Over-Sensing	1076	1076
Incorrect, Inadequate or Imprecise Result or Readings	1020	1020
Premature Discharge of Battery	1004	1004
Pacing Problem	853	853
High impedance	681	681
Signal Artifact/Noise	385	385
Failure to Capture	347	347
Inappropriate or Unexpected Reset	281	281
Pacemaker Found in Back-Up Mode	277	277
Unable to Obtain Readings	231	231
Device Operates Differently Than Expected	224	224
Defective Device	223	223
Low impedance	213	213
Appropriate Term/Code Not Available	189	189
Battery Problem	182	182
Ambient Noise Problem	154	154
Mechanical Problem	151	151
Failure to Interrogate	147	147
Reset Problem	144	144
Device Sensing Problem	134	134
Under-Sensing	132	132
High Capture Threshold	131	131
Impedance Problem	106	106
Incorrect Measurement	100	100
Connection Problem	94	94
Device Displays Incorrect Message	94	94
Capturing Problem	93	93
Telemetry Discrepancy	88	88
Data Problem	83	83
Use of Device Problem	82	82
Interrogation Problem	71	71
Off-Label Use	67	67
Pocket Stimulation	63	63
False Alarm	63	63
Communication or Transmission Problem	58	58
Premature Elective Replacement Indicator	57	57
Failure to Read Input Signal	54	54
Loose or Intermittent Connection	53	53
Misconnection	51	51
Insufficient Information	46	46
Migration or Expulsion of Device	41	41
No Pacing	38	38
Electromagnetic Interference	38	38
Output Problem	34	34
Operating System Version or Upgrade Problem	33	33
No Device Output	29	29
Difficult to Insert	29	29
Difficult to Interrogate	24	24
Nonstandard Device	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2899	2899
No Known Impact Or Consequence To Patient	1987	1987
Unspecified Infection	1877	1877
No Consequences Or Impact To Patient	354	354
Sepsis	255	255
Pocket Erosion	236	236
Insufficient Information	215	215
No Code Available	214	214
Syncope/Fainting	177	177
Bradycardia	165	165
Device Overstimulation of Tissue	158	158
Dizziness	153	153
Death	142	142
Hematoma	142	142
Discomfort	123	123
Syncope	122	122
Asystole	121	121
Erosion	96	96
Pain	88	88
Dyspnea	82	82
No Patient Involvement	77	77
Muscle Stimulation	73	73
Bacterial Infection	62	62
Fatigue	58	58
Cardiac Arrest	55	55
Complaint, Ill-Defined	55	55
Fall	51	51
Arrhythmia	48	48
Endocarditis	47	47
Wound Dehiscence	44	44
Chest Pain	42	42
Undesired Nerve Stimulation	41	41
Purulent Discharge	39	39
Erythema	39	39
Presyncope	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	35
Fever	32	32
Atrial Fibrillation	31	31
Swelling/ Edema	31	31
Swelling	27	27
Tachycardia	27	27
Unspecified Heart Problem	22	22
Palpitations	18	18
Non specific EKG/ECG Changes	17	17
Loss of consciousness	17	17
No Information	16	16
Low Blood Pressure/ Hypotension	16	16
Heart Failure/Congestive Heart Failure	15	15
Septic Shock	14	14
Head Injury	14	14

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Jul-13-2021
2	Boston Scientific Corporation	II	Jul-02-2021
3	Boston Scientific Corporation	II	Jan-15-2018
4	Medtronic Inc.	II	Nov-27-2015
5	Medtronic Inc. Cardiac Rhythm Disease Management	II	Jun-27-2013
6	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Apr-30-2021
7	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jul-10-2018
8	St Jude Medical Inc.	II	Jun-12-2018