TPLC - Total Product Life Cycle

• Device: drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
• Definition: Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
• Product Code: NVN
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
56	69	60	43	38	34

MDR Year	MDR Reports	MDR Events
2019	16872	16872
2020	16529	16529
2021	17756	17756
2022	18200	18200
2023	24999	24999
2024	20313	20314

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	22348	22349
Over-Sensing	21258	21258
Device Dislodged or Dislocated	16898	16898
Signal Artifact/Noise	14411	14411
Failure to Capture	13377	13377
High Capture Threshold	12850	12850
High impedance	10195	10195
Break	6375	6375
Pacing Problem	5853	5853
Capturing Problem	5785	5785
Under-Sensing	5522	5522
Low impedance	5326	5326
Fracture	4517	4517
Device Sensing Problem	3642	3642
Impedance Problem	2529	2529
Mechanical Problem	2401	2401
Defective Device	2335	2335
Failure to Sense	2170	2170
Positioning Problem	2102	2102
Insufficient Information	1953	1953
Material Integrity Problem	1761	1761
Difficult to Fold, Unfold or Collapse	1575	1575
Ambient Noise Problem	1506	1506
No Apparent Adverse Event	1105	1105
Intermittent Capture	1072	1072
Use of Device Problem	958	958
Decreased Sensitivity	951	951
Failure to Read Input Signal	882	882
Retraction Problem	859	859
Unstable Capture Threshold	743	743
Appropriate Term/Code Not Available	717	717
Material Twisted/Bent	665	665
Therapy Delivered to Incorrect Body Area	570	570
Failure to Advance	526	526
Electrical /Electronic Property Problem	512	512
Off-Label Use	498	498
Difficult to Remove	408	408
Difficult to Insert	394	394
Low Sensing Threshold	372	372
No Pacing	305	305
Failure to Disconnect	293	293
Pacing Intermittently	252	252
Naturally Worn	230	230
Activation, Positioning or Separation Problem	198	198
Pocket Stimulation	192	192
Connection Problem	181	181
Therapeutic or Diagnostic Output Failure	173	173
Inappropriate/Inadequate Shock/Stimulation	154	154
Stretched	140	140
Patient-Device Incompatibility	130	130

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55916	55916
Unspecified Infection	17648	17650
No Known Impact Or Consequence To Patient	17407	17407
No Consequences Or Impact To Patient	4674	4674
Insufficient Information	3856	3856
No Code Available	2770	2770
Sepsis	2054	2054
Cardiac Perforation	1951	1951
Discomfort	1584	1584
Dizziness	1522	1522
Pocket Erosion	1256	1256
Syncope/Fainting	1100	1100
Arrhythmia	1041	1041
Bradycardia	890	890
Pericardial Effusion	794	794
Dyspnea	734	734
Death	714	714
Chest Pain	645	645
Bacterial Infection	605	605
Perforation	585	585
Pain	529	529
No Information	469	469
Syncope	435	435
Asystole	380	380
Twiddlers Syndrome	377	377
Endocarditis	362	362
Fatigue	350	350
Failure of Implant	344	344
Twiddlers Syndrome	338	339
Muscle Stimulation	338	338
Device Overstimulation of Tissue	323	323
Erosion	317	317
Fever	300	300
Fall	258	258
Undesired Nerve Stimulation	256	256
Wound Dehiscence	253	253
Swelling/ Edema	246	246
Tachycardia	233	233
Foreign Body In Patient	230	230
Hematoma	228	228
Cardiac Tamponade	226	226
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	226	226
Purulent Discharge	212	212
Erythema	189	189
Heart Block	177	177
Low Blood Pressure/ Hypotension	177	177
Cardiac Arrest	169	169
Pneumothorax	161	161
Heart Failure/Congestive Heart Failure	159	159
Atrial Fibrillation	159	159