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)
2021	2022	2023	2024	2025	2026
60	43	38	36	36	14

MDR Year	MDR Reports	MDR Events
2021	17757	17764
2022	18200	18237
2023	24992	25031
2024	22012	22037
2025	23654	23656
2026	5756	5756

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	21641	21658
Over-Sensing	20903	20921
Device Dislodged or Dislocated	16141	16163
Failure to Capture	13414	13434
High Capture Threshold	11424	11438
High impedance	9986	9999
Signal Artifact/Noise	9268	9281
Pacing Problem	7115	7128
Capturing Problem	6962	6968
Under-Sensing	6067	6071
Break	5886	5889
Low impedance	5051	5059
Fracture	4554	4557
Device Sensing Problem	3337	3343
Defective Device	3218	3222
Insufficient Information	2908	2910
Impedance Problem	2695	2698
Positioning Problem	2134	2136
Difficult to Fold, Unfold or Collapse	2132	2135
Failure to Sense	1893	1897
Mechanical Problem	1796	1797
Material Integrity Problem	1475	1478
Ambient Noise Problem	1302	1302
Use of Device Problem	1185	1185
No Apparent Adverse Event	1148	1149
Failure to Read Input Signal	1107	1108
Intermittent Capture	999	1000
Retraction Problem	937	937
Decreased Sensitivity	923	924
Unstable Capture Threshold	836	838
Material Twisted/Bent	765	765
Appropriate Term/Code Not Available	717	720
Therapy Delivered to Incorrect Body Area	654	654
Electrical /Electronic Property Problem	601	602
Failure to Advance	570	570
Off-Label Use	538	538
Difficult to Remove	398	400
Failure to Disconnect	369	370
Pacing Intermittently	238	238
Therapeutic or Diagnostic Output Failure	207	207
Naturally Worn	201	201
No Pacing	193	193
Connection Problem	183	186
Output Problem	182	182
Contamination /Decontamination Problem	181	181
Activation, Positioning or Separation Problem	164	164
Stretched	161	161
Contamination of Device Ingredient or Reagent	146	146
Inappropriate/Inadequate Shock/Stimulation	131	132
Difficult to Insert	130	131

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76200	76278
Unspecified Infection	17538	17545
Insufficient Information	4961	4963
Discomfort	1924	1925
Cardiac Perforation	1799	1804
Syncope/Fainting	1467	1471
Dizziness	1428	1431
Sepsis	1336	1336
Pocket Erosion	1267	1268
Arrhythmia	1261	1262
Bradycardia	927	929
Dyspnea	713	714
Pericardial Effusion	710	712
Bacterial Infection	684	684
No Code Available	597	597
Perforation	589	591
Chest Pain	550	551
Pain	533	535
Asystole	531	532
Twiddlers Syndrome	487	487
Failure of Implant	484	487
Device Overstimulation of Tissue	436	436
Swelling/ Edema	408	408
Fever	353	353
Erythema	344	344
Fatigue	344	346
Foreign Body In Patient	338	338
Erosion	337	338
Endocarditis	328	328
Purulent Discharge	320	320
Wound Dehiscence	294	294
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	284	284
No Consequences Or Impact To Patient	281	281
Tachycardia	264	264
Heart Failure/Congestive Heart Failure	243	243
Fall	239	240
Hematoma	236	236
Heart Block	232	236
Presyncope	212	212
Cardiac Tamponade	210	210
Low Blood Pressure/ Hypotension	192	192
Obstruction/Occlusion	176	177
Undesired Nerve Stimulation	169	169
Atrial Fibrillation	166	167
Pneumothorax	155	156
Cardiac Arrest	147	148
Thrombosis/Thrombus	128	128
Hypersensitivity/Allergic reaction	120	120
Fluid Discharge	117	117
Hemorrhage/Bleeding	108	108