TPLC - Total Product Life Cycle

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Device	implantable pacemaker pulse-generator
Regulation Description	Implantable pacemaker pulse generator.
Product Code	DXY
Regulation Number	870.3610
Device Class	3

Premarket Approvals (PMA)
2018	2019	2020	2021	2022	2023	2024	2025	2026
45	19	23	20	14	19	20	19	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2187	2187
Over-Sensing	921	922
Device Dislodged or Dislocated	726	726
Signal Artifact/Noise	686	687
Failure to Capture	541	541
Premature Discharge of Battery	506	507
High Capture Threshold	436	438
Appropriate Device Problem Term/Code Not Available	378	379
High impedance	372	373
Pacing Problem	322	324
Failure to Interrogate	300	300
Under-Sensing	280	281
Inappropriate/Inadequate Shock/Stimulation	259	259
Pacemaker Found in Back-Up Mode	255	257
Device Sensing Problem	246	246
Impedance Problem	239	240
Fracture	222	222
Break	207	207
Low impedance	187	187
Capturing Problem	183	183
No Pacing	154	154
Insufficient Device Problem Information	124	124
Data Problem	118	119
Incorrect Measurement	116	116
Decreased Sensitivity	100	100
Failure to Sense	97	97
Connection Problem	94	95
Failure to Disconnect	92	93
Mechanical Problem	87	87
Battery Problem	84	84
Loose or Intermittent Connection	79	80
Incorrect, Inadequate or Imprecise Result or Readings	77	77
Defective Device	71	72
Unexpected Mode Switch	63	63
Interrogation Problem	63	63
Misconnection	63	63
Intermittent Capture	55	55
Difficult to Remove	55	58
Electrical /Electronic Property Problem	54	55
Positioning Problem	51	51
Unstable Capture Threshold	51	51
Communication or Transmission Problem	46	46
Inappropriate or Unexpected Reset	43	43
Output Problem	41	41
Wireless Communication Problem	37	37
Difficult to Insert	36	36
Material Integrity Problem	35	36
Low Sensing Threshold	34	34
Electromagnetic Interference	27	27
Retraction Problem	25	25

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2679	2698
No Known Impact Or Consequence To Patient	2343	2344
Unspecified Infection	1419	1419
Insufficient Information	337	337
Death	251	251
Shock from Patient Lead(s)	248	248
No Consequences Or Impact To Patient	162	162
Arrhythmia	138	139
Dizziness	133	135
Pericardial Effusion	127	127
Pocket Erosion	114	114
Syncope/Fainting	106	106
Cardiac Arrest	102	102
Pneumothorax	98	98
Dyspnea	97	98
Cardiac Perforation	91	91
Bradycardia	86	86
Heart Failure/Congestive Heart Failure	86	86
Chest Pain	84	84
Syncope	84	86
Sepsis	84	84
Discomfort	79	80
Endocarditis	79	79
Hematoma	76	76
No Information	75	75
Cardiac Tamponade	71	71
Bacterial Infection	64	64
Erosion	61	61
Pain	50	50
Twiddlers Syndrome	50	50
Tachycardia	49	49
Muscle Stimulation	46	46
Fatigue	45	45
Undesired Nerve Stimulation	45	45
No Code Available	44	44
Fever	42	42
Complaint, Ill-Defined	40	40
Atrial Fibrillation	39	39
Wound Dehiscence	37	37
Ventricular Fibrillation	37	37
Tricuspid Valve Insufficiency/ Regurgitation	34	34
Hemorrhage/Blood Loss/Bleeding	34	34
Palpitations	34	34
Thrombosis/Thrombus	34	34
Asystole	32	32
Stroke/CVA	32	32
Swelling	31	31
Hemothorax	31	31
Low Blood Pressure/ Hypotension	29	29
Device Overstimulation of Tissue	26	26

Recalls
Manufacturer		Recall Class	Date Posted
1	St Jude Medical Inc.	II	Jun-12-2018
2	St. Jude Medical, Cardiac Rhythm Management Division	II	Aug-02-2022