TPLC - Total Product Life Cycle

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Device	electrode, pacemaker, temporary
Regulation Description	Cardiovascular permanent or temporary pacemaker electrode.
Product Code	LDF
Regulation Number	870.3680
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOPTIMAL INTERNATIONAL PTE. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSYPKA AG
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LAUNCH ELECTRICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pacing Problem	194	195
Break	101	101
Inflation Problem	64	65
Material Separation	57	57
Adverse Event Without Identified Device or Use Problem	55	56
No Pacing	40	41
Material Integrity Problem	27	27
Patient Device Interaction Problem	20	20
Insufficient Information	19	19
Detachment of Device or Device Component	19	22
Deformation Due to Compressive Stress	18	18
Fracture	18	23
Burst Container or Vessel	13	13
Material Frayed	11	15
Material Puncture/Hole	10	10
Connection Problem	9	10
Material Twisted/Bent	9	9
Gas/Air Leak	9	9
Device Dislodged or Dislocated	9	9
Failure to Sense	9	9
Accessory Incompatible	8	8
Material Rupture	8	8
Material Split, Cut or Torn	7	7
Failure to Infuse	7	8
Failure to Capture	7	7
Material Deformation	6	6
Positioning Failure	6	6
Disconnection	5	5
Material Too Rigid or Stiff	5	5
Device Sensing Problem	5	5
Fluid/Blood Leak	4	4
Device Markings/Labelling Problem	4	4
Difficult to Advance	4	4
Difficult to Remove	4	4
Material Fragmentation	4	4
Defibrillation/Stimulation Problem	3	3
Component Misassembled	3	3
Pacing Inadequately	3	3
Appropriate Term/Code Not Available	3	3
Nonstandard Device	3	3
Tear, Rip or Hole in Device Packaging	2	2
Material Protrusion/Extrusion	2	2
Unstable Capture Threshold	2	2
Over-Sensing	2	2
Loss of Threshold	2	2
Delivered as Unsterile Product	2	2
Naturally Worn	2	2
Improper or Incorrect Procedure or Method	2	2
Decrease in Pressure	2	2
Use of Device Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	586	593
Insufficient Information	48	48
Cardiac Perforation	37	37
Exposure to Body Fluids	31	31
Cardiac Arrest	28	28
Cardiac Tamponade	24	24
Arrhythmia	20	20
Ventricular Fibrillation	11	11
Hemorrhage/Bleeding	10	10
Pericardial Effusion	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Unspecified Infection	8	8
Heart Block	7	7
Tachycardia	7	8
Perforation	6	6
Asystole	6	7
Bradycardia	6	6
No Consequences Or Impact To Patient	4	4
Failure of Implant	3	3
Atrial Fibrillation	3	3
Foreign Body In Patient	3	3
Unspecified Tissue Injury	3	4
Dizziness	2	2
Vascular Dissection	2	2
Low Blood Pressure/ Hypotension	2	2
Bacterial Infection	2	2
Aortic Valve Insufficiency/ Regurgitation	2	2
Multiple Organ Failure	2	2
Pneumothorax	2	2
Stroke/CVA	2	2
Loss of consciousness	2	2
Myocardial Infarction	2	2
Chest Pain	2	2
Septic Shock	2	2
Vomiting	2	2
Perforation of Vessels	2	2
Thromboembolism	1	1
Unspecified Vascular Problem	1	1
Tissue Breakdown	1	1
Erosion	1	1
Device Embedded In Tissue or Plaque	1	1
Fistula	1	1
Unspecified Heart Problem	1	1
Pseudoaneurysm	1	1
Pulmonary Embolism	1	1
Fluid Discharge	1	1
Laceration(s)	1	1
Dyspnea	1	1
Discomfort	1	1
Micturition Urgency	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024