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
SWIFT SYNC, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pacing Problem	209	210
Break	108	108
Inflation Problem	67	68
Material Separation	58	58
Adverse Event Without Identified Device or Use Problem	57	58
No Pacing	48	49
Material Integrity Problem	29	29
Insufficient Device Problem Information	21	21
Patient Device Interaction Problem	19	19
Detachment of Device or Device Component	19	22
Deformation Due to Compressive Stress	18	18
Fracture	18	23
Material Rupture	13	13
Burst Container or Vessel	13	13
Material Frayed	10	14
Device Dislodged or Dislocated	10	10
Material Puncture/Hole	10	10
Gas/Air Leak	10	10
Fluid/Blood Leak	9	9
Failure to Capture	9	9
Connection Problem	9	10
Material Twisted/Bent	9	9
Difficult to Advance	9	9
Failure to Sense	9	9
Positioning Failure	9	9
Material Deformation	8	8
Accessory Incompatible	8	8
Material Too Rigid or Stiff	8	8
Appropriate Device Problem Term/Code Not Available	8	8
Material Split, Cut or Torn	7	7
Failure to Infuse	7	8
Use of Device Problem	5	5
Device Sensing Problem	5	5
Difficult to Insert	5	5
Component Misassembled	5	5
Disconnection	5	5
Material Fragmentation	4	4
Difficult to Remove	4	4
Device Markings/Labelling Problem	4	4
Nonstandard Device	4	4
Defibrillation/Stimulation Problem	3	3
Unintended System Motion	3	3
Improper or Incorrect Procedure or Method	3	3
Device Contamination with Chemical or Other Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Protrusion/Extrusion	2	2
Missing Information	2	2
Loss of Threshold	2	2
Product Quality Problem	2	2
Naturally Worn	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	656	663
Insufficient Information	56	56
Cardiac Perforation	38	38
Exposure to Body Fluids	33	33
Cardiac Arrest	28	28
Cardiac Tamponade	25	25
Arrhythmia	20	20
Hemorrhage/Blood Loss/Bleeding	14	14
Pericardial Effusion	12	12
Ventricular Fibrillation	11	11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
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
Perforation of Vessels	4	4
Atrial Fibrillation	3	3
Failure of Implant	3	3
Foreign Body In Patient	3	3
Loss of consciousness	3	3
Unspecified Tissue Injury	3	4
Vascular Dissection	2	2
Hematoma	2	2
Multiple Organ Dysfunction Syndrome	2	2
Dizziness	2	2
Low Blood Pressure/ Hypotension	2	2
Pneumothorax	2	2
Stroke/CVA	2	2
Aortic Valve Insufficiency/ Regurgitation	2	2
Bacterial Infection	2	2
Chest Pain	2	2
Septic Shock	2	2
Vomiting	2	2
Myocardial Infarction	2	2
Device Embedded In Tissue or Plaque	1	1
Fistula	1	1
Pulmonary Embolism	1	1
Tissue Breakdown	1	1
Unspecified Vascular Problem	1	1
Thromboembolism	1	1
Erosion	1	1
Unspecified Heart Problem	1	1
Pseudoaneurysm	1	1
Fluid Discharge	1	1
Increased Appetite	1	1
Laceration(s)	1	1
Dyspnea	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL, LLC	I	Jun-13-2026
2	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024