TPLC - Total Product Life Cycle

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Device	electrode, pacemaker, temporary
Product Code	LDF
Regulation Number	870.3680
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pacing Problem	320	320
Break	124	124
Adverse Event Without Identified Device or Use Problem	82	82
No Pacing	73	73
Inflation Problem	72	72
Material Separation	55	55
Material Integrity Problem	30	30
Detachment of Device or Device Component	25	25
Fracture	25	25
Material Rupture	19	19
Deformation Due to Compressive Stress	19	19
Insufficient Information	18	18
Failure to Sense	16	16
Connection Problem	16	16
Failure to Capture	15	15
Burst Container or Vessel	15	15
Material Too Rigid or Stiff	14	14
Appropriate Term/Code Not Available	13	13
Material Frayed	11	11
Detachment Of Device Component	11	11
Patient Device Interaction Problem	11	11
Device Dislodged or Dislocated	11	11
Gas/Air Leak	10	10
Material Fragmentation	10	10
Failure to Infuse	10	10
Material Twisted/Bent	9	9
Disconnection	9	9
Leak/Splash	8	8
Material Puncture/Hole	8	8
Material Split, Cut or Torn	8	8
Fluid/Blood Leak	7	7
Device Sensing Problem	7	7
Accessory Incompatible	6	6
Deflation Problem	6	6
Over-Sensing	6	6
Use of Device Problem	6	6
Nonstandard Device	5	5
Device Operates Differently Than Expected	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Tear, Rip or Hole in Device Packaging	5	5
Loss of Threshold	5	5
Improper or Incorrect Procedure or Method	5	5
Material Deformation	4	4
Pacing Inadequately	4	4
Defective Component	4	4
Defective Device	4	4
Device Damaged Prior to Use	4	4
Electrical /Electronic Property Problem	4	4
Difficult to Remove	4	4
Capturing Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	435	435
No Consequences Or Impact To Patient	243	243
No Known Impact Or Consequence To Patient	193	193
Cardiac Perforation	55	55
Cardiac Tamponade	50	51
Exposure to Body Fluids	31	31
Cardiac Arrest	30	31
Insufficient Information	28	28
Arrhythmia	24	25
No Information	22	22
Death	21	21
Pericardial Effusion	19	19
No Patient Involvement	17	17
Hemorrhage/Bleeding	12	12
Perforation	12	12
No Code Available	11	11
Foreign Body In Patient	10	10
Ventricular Fibrillation	10	10
Unspecified Infection	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Bradycardia	8	8
Low Blood Pressure/ Hypotension	8	8
Tachycardia	7	7
Device Embedded In Tissue or Plaque	7	7
Atrial Fibrillation	6	6
Asystole	5	5
Cardiopulmonary Arrest	5	5
Blood Loss	5	5
Internal Organ Perforation	5	5
Complete Heart Block	4	4
Heart Block	4	4
Not Applicable	4	4
Failure of Implant	4	4
Loss of consciousness	3	3
Erosion	3	3
Myocardial Infarction	3	3
Unspecified Tissue Injury	3	3
Pain	3	3
Rupture	2	2
Aortic Valve Stenosis	2	2
Dizziness	2	2
Aortic Valve Insufficiency/ Regurgitation	2	2
Ventricular Tachycardia	2	2
Needle Stick/Puncture	2	2
Loss Of Pulse	2	2
Bacterial Infection	2	2
Chest Pain	2	2
Thrombosis	2	2
Increased Sensitivity	2	2
Pneumothorax	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Alto Development Corp	II	Jul-29-2019
2	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
3	Medtronic Inc., Cardiac Rhythm and Heart Failure	II	Sep-19-2016
4	Oscor, Inc.	I	Nov-08-2018