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	288	288
Break	117	117
Adverse Event Without Identified Device or Use Problem	80	80
Inflation Problem	70	70
No Pacing	70	70
Material Separation	54	54
Material Integrity Problem	28	28
Detachment of Device or Device Component	25	25
Fracture	24	24
Deformation Due to Compressive Stress	19	19
Insufficient Information	18	18
Failure to Sense	16	16
Material Rupture	15	15
Burst Container or Vessel	15	15
Failure to Capture	14	14
Material Too Rigid or Stiff	12	12
Connection Problem	12	12
Patient Device Interaction Problem	11	11
Material Frayed	11	11
Gas/Air Leak	10	10
Appropriate Term/Code Not Available	10	10
Device Dislodged or Dislocated	10	10
Failure to Infuse	10	10
Material Twisted/Bent	9	9
Material Fragmentation	8	8
Material Puncture/Hole	8	8
Material Split, Cut or Torn	8	8
Leak/Splash	8	8
Device Sensing Problem	7	7
Disconnection	7	7
Fluid/Blood Leak	7	7
Accessory Incompatible	6	6
Use of Device Problem	5	5
Deflation Problem	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Nonstandard Device	5	5
Loss of Threshold	5	5
Tear, Rip or Hole in Device Packaging	5	5
Over-Sensing	4	4
Material Deformation	4	4
Difficult to Remove	4	4
Device Damaged Prior to Use	4	4
Pacing Inadequately	4	4
Defective Device	4	4
Defective Component	4	4
Detachment Of Device Component	4	4
Difficult to Insert	3	3
Difficult to Advance	3	3
Intermittent Capture	3	3
Impedance Problem	3	3

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	207	207
No Known Impact Or Consequence To Patient	159	159
Cardiac Perforation	55	55
Cardiac Tamponade	47	48
Exposure to Body Fluids	31	31
Insufficient Information	28	28
Cardiac Arrest	28	29
Arrhythmia	23	24
No Information	20	20
Pericardial Effusion	18	18
No Patient Involvement	17	17
Death	16	16
Hemorrhage/Bleeding	12	12
Perforation	11	11
Ventricular Fibrillation	10	10
No Code Available	9	9
Foreign Body In Patient	8	8
Unspecified Infection	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Low Blood Pressure/ Hypotension	8	8
Tachycardia	7	7
Bradycardia	7	7
Atrial Fibrillation	6	6
Asystole	5	5
Device Embedded In Tissue or Plaque	5	5
Failure of Implant	4	4
Not Applicable	4	4
Cardiopulmonary Arrest	4	4
Heart Block	4	4
Internal Organ Perforation	4	4
Blood Loss	4	4
Loss of consciousness	3	3
Erosion	3	3
Myocardial Infarction	3	3
Unspecified Tissue Injury	3	3
Bacterial Infection	2	2
Chest Pain	2	2
Thrombosis	2	2
Pain	2	2
Perforation of Vessels	2	2
Needle Stick/Puncture	2	2
Aortic Valve Insufficiency/ Regurgitation	2	2
Aortic Valve Stenosis	2	2
Complete Heart Block	2	2
Dizziness	2	2
Ventricular Tachycardia	2	2
Increased Sensitivity	2	2
Pneumothorax	2	2
Stroke/CVA	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	Oscor, Inc.	I	Nov-08-2018