TPLC - Total Product Life Cycle

• Device: permanent pacemaker electrode
• Regulation Description: Cardiovascular permanent or temporary pacemaker electrode.
• Product Code: DTB
• Regulation Number: 870.3680
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
6	3	4	7	3	1

MDR Year	MDR Reports	MDR Events
2020	17859	17859
2021	18442	18442
2022	19444	19444
2023	34542	34542
2024	25689	25689
2025	22178	22179

Device Problems	MDRs with this Device Problem	Events in those MDRs
Under-Sensing	36833	36833
Adverse Event Without Identified Device or Use Problem	23449	23449
Over-Sensing	22196	22196
High Capture Threshold	19663	19663
High impedance	11766	11766
Device Dislodged or Dislocated	10531	10531
Failure to Capture	9579	9579
Signal Artifact/Noise	9366	9366
Pacing Problem	7801	7802
Impedance Problem	7025	7025
Fracture	5932	5932
Low impedance	5488	5488
Decreased Sensitivity	5354	5354
Electrical /Electronic Property Problem	5053	5053
Capturing Problem	4911	4911
Positioning Problem	3863	3863
Appropriate Term/Code Not Available	2530	2530
Break	2373	2373
Unstable Capture Threshold	2224	2224
Activation, Positioning or Separation Problem	1897	1897
Device Sensing Problem	1836	1836
Insufficient Information	1382	1382
Intermittent Capture	1351	1351
Material Integrity Problem	1289	1289
Defective Device	927	927
Positioning Failure	646	646
Mechanical Problem	404	404
Therapeutic or Diagnostic Output Failure	401	401
No Apparent Adverse Event	365	365
Material Twisted/Bent	313	313
Inappropriate/Inadequate Shock/Stimulation	221	221
Failure to Read Input Signal	206	206
Connection Problem	199	199
Difficult to Remove	195	195
Electromagnetic Interference	192	192
Device-Device Incompatibility	175	175
Collapse	166	166
Pocket Stimulation	160	160
High Sensing Threshold	160	160
Use of Device Problem	146	146
Premature Activation	136	136
Ambient Noise Problem	112	112
Product Quality Problem	101	101
Output Problem	97	97
Pacemaker Found in Back-Up Mode	91	91
Device Contamination with Body Fluid	89	89
Off-Label Use	86	86
No Pacing	83	83
Failure to Sense	72	72
Material Split, Cut or Torn	67	67

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	84877	84878
Unspecified Infection	17212	17212
No Consequences Or Impact To Patient	5916	5916
Insufficient Information	4689	4689
No Known Impact Or Consequence To Patient	4370	4370
Chest Pain	2206	2206
Dizziness	1995	1995
Bradycardia	1888	1888
Dyspnea	1882	1882
Syncope/Fainting	1850	1850
Sepsis	1560	1560
Arrhythmia	1432	1432
Bacterial Infection	1426	1426
Pocket Erosion	1351	1351
Cardiac Perforation	1322	1322
Pericardial Effusion	1249	1249
Discomfort	1235	1235
Erythema	1192	1192
No Code Available	1148	1148
Erosion	1105	1105
Pain	1006	1006
Swelling/ Edema	869	869
Tachycardia	847	847
Fall	771	771
Purulent Discharge	765	765
Device Overstimulation of Tissue	759	759
Endocarditis	757	757
Fever	703	703
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	674	674
Obstruction/Occlusion	638	638
Atrial Fibrillation	612	612
Wound Dehiscence	578	578
Cardiac Arrest	560	560
Undesired Nerve Stimulation	473	473
Perforation	461	461
Cardiac Tamponade	452	452
Heart Block	452	452
Asystole	447	447
Presyncope	441	441
Fatigue	424	424
Muscle Weakness	408	408
Low Blood Pressure/ Hypotension	390	390
Non specific EKG/ECG Changes	388	388
Twiddlers Syndrome	370	370
Hematoma	345	345
Shock from Patient Lead(s)	330	330
Drug Resistant Bacterial Infection	327	327
Foreign Body In Patient	325	325
Failure of Implant	282	282
Heart Failure/Congestive Heart Failure	242	242