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
1. K242863 Bioptimal Bipolar Pacing Catheter
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	201	202
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	29	29
Patient Device Interaction Problem	20	20
Detachment of Device or Device Component	19	22
Insufficient Information	19	19
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
Material Twisted/Bent	9	9
Gas/Air Leak	9	9
Material Rupture	9	9
Failure to Sense	9	9
Device Dislodged or Dislocated	9	9
Connection Problem	9	10
Accessory Incompatible	8	8
Failure to Capture	8	8
Failure to Infuse	7	8
Material Split, Cut or Torn	7	7
Material Deformation	6	6
Positioning Failure	6	6
Device Sensing Problem	5	5
Material Too Rigid or Stiff	5	5
Disconnection	5	5
Device Markings/Labelling Problem	4	4
Difficult to Advance	4	4
Difficult to Remove	4	4
Material Fragmentation	4	4
Fluid/Blood Leak	4	4
Pacing Inadequately	3	3
Component Misassembled	3	3
Appropriate Term/Code Not Available	3	3
Defibrillation/Stimulation Problem	3	3
Nonstandard Device	3	3
Over-Sensing	2	2
Loss of Threshold	2	2
Material Protrusion/Extrusion	2	2
Tear, Rip or Hole in Device Packaging	2	2
Unstable Capture Threshold	2	2
Delivered as Unsterile Product	2	2
Naturally Worn	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	2	2
Communication or Transmission Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	596	603
Insufficient Information	49	49
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
Increased Appetite	1	1
Laceration(s)	1	1
Dyspnea	1	1
Discomfort	1	1

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