TPLC - Total Product Life Cycle

• Device: permanent pacemaker electrode
• Product Code: DTB
• Regulation Number: 870.3680
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	0	0	3	8	5	6	7	6	3	4	7	1

MDR Year	MDR Reports	MDR Events
2014	13317	13317
2015	11069	11069
2016	11835	11835
2017	11494	11502
2018	15208	15216
2019	16812	16812
2020	17859	17859
2021	18441	18441
2022	19444	19444
2023	34552	34552
2024	17329	17329

Device Problems	MDRs with this Device Problem	Events in those MDRs
Under-Sensing	38263	38263
High Capture Threshold	29099	29099
Adverse Event Without Identified Device or Use Problem	28537	28553
Over-Sensing	28259	28259
Device Dislodged or Dislocated	20375	20375
High impedance	19377	19377
Failure to Capture	16375	16375
Signal Artifact/Noise	11390	11390
Fracture	10518	10518
Impedance Problem	8905	8905
Low impedance	8482	8482
Capturing Problem	8437	8437
Pacing Problem	7221	7221
Positioning Problem	5949	5949
Decreased Sensitivity	5698	5698
Electrical /Electronic Property Problem	4441	4441
Activation, Positioning or Separation Problem	4027	4027
Appropriate Term/Code Not Available	3933	3933
Break	3891	3891
Device Sensing Problem	3885	3885
Unstable Capture Threshold	3691	3691
Material Integrity Problem	3003	3003
Intermittent Capture	2403	2403
Positioning Failure	1747	1747
Insufficient Information	1713	1713
Failure to Sense	1333	1333
Ambient Noise Problem	1257	1257
Device Operates Differently Than Expected	981	981
Defective Device	928	928
Mechanical Problem	651	651
Connection Problem	647	647
Electronic Property Issue	606	606
Pocket Stimulation	512	512
Difficult to Remove	463	463
High Sensing Threshold	387	387
Therapeutic or Diagnostic Output Failure	383	383
No Apparent Adverse Event	379	379
Material Twisted/Bent	350	350
Degraded	347	347
Collapse	321	321
Inappropriate/Inadequate Shock/Stimulation	320	320
Premature Activation	283	283
Electromagnetic Interference	282	282
Human-Device Interface Problem	253	253
Bent	253	253
Device-Device Incompatibility	238	238
Use of Device Problem	192	192
Device Contamination with Body Fluid	165	165
Failure to Read Input Signal	150	150
Difficult To Position	143	143

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	62607	62607
No Known Impact Or Consequence To Patient	56849	56851
Unspecified Infection	20593	20610
No Consequences Or Impact To Patient	10838	10838
Insufficient Information	4438	4438
Dizziness	2819	2819
No Code Available	2618	2619
Chest Pain	2607	2607
Cardiac Perforation	2572	2572
Sepsis	2535	2535
Bradycardia	2328	2328
Dyspnea	2252	2252
Pericardial Effusion	1940	1940
Syncope	1840	1840
Death	1591	1591
Pocket Erosion	1502	1510
Syncope/Fainting	1437	1437
Muscle Stimulation	1422	1422
Arrhythmia	1347	1347
Bacterial Infection	1235	1235
Endocarditis	1230	1230
Pain	1171	1172
Erosion	1151	1151
Cardiac Arrest	1049	1049
Discomfort	1009	1009
Fall	993	993
Undesired Nerve Stimulation	965	965
Cardiac Tamponade	834	834
Atrial Fibrillation	825	825
Tachycardia	802	802
Perforation	801	801
Fatigue	683	683
Complaint, Ill-Defined	668	668
Erythema	659	659
Device Overstimulation of Tissue	635	635
Twiddlers Syndrome	580	580
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	567	567
Palpitations	551	551
Fever	527	527
Wound Dehiscence	522	522
Hematoma	511	511
Low Blood Pressure/ Hypotension	503	503
Swelling/ Edema	500	500
Obstruction/Occlusion	490	490
Non specific EKG/ECG Changes	471	471
Purulent Discharge	465	465
Shock from Patient Lead(s)	402	402
Heart Block	374	374
Pneumothorax	360	360
No Information	350	350

Recalls
Manufacturer		Recall Class	Date Posted
1	Greatbatch Medical	II	Nov-02-2010
2	Greatbatch Medical	II	Dec-29-2009
3	Medtronic Inc. Cardiac Rhythm Disease Management	II	Oct-05-2015
4	Medtronic Inc. Cardiac Rhythm Disease Managment	II	Mar-23-2010