TPLC - Total Product Life Cycle

show TPLC since

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
C. R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	199	199
Break	101	101
Inflation Problem	58	58
Adverse Event Without Identified Device or Use Problem	52	52
No Pacing	52	52
Material Separation	50	50
Material Integrity Problem	25	25
Fracture	20	20
Deformation Due to Compressive Stress	19	19
Detachment of Device or Device Component	19	19
Insufficient Information	17	17
Patient Device Interaction Problem	16	16
Burst Container or Vessel	15	15
Material Frayed	11	11
Connection Problem	10	10
Material Rupture	10	10
Material Too Rigid or Stiff	10	10
Material Puncture/Hole	10	10
Gas/Air Leak	9	9
Failure to Sense	9	9
Material Twisted/Bent	8	8
Device Dislodged or Dislocated	8	8
Failure to Infuse	8	8
Failure to Capture	8	8
Material Split, Cut or Torn	7	7
Device Sensing Problem	6	6
Disconnection	5	5
Fluid/Blood Leak	5	5
Accessory Incompatible	5	5
Loss of Threshold	5	5
Material Fragmentation	5	5
Difficult to Remove	5	5
Material Deformation	4	4
Positioning Failure	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Difficult to Advance	4	4
Device Markings/Labelling Problem	4	4
Component Misassembled	3	3
Pacing Inadequately	3	3
Nonstandard Device	3	3
Product Quality Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Protrusion/Extrusion	2	2
Difficult or Delayed Separation	2	2
Unstable Capture Threshold	2	2
Naturally Worn	2	2
Improper or Incorrect Procedure or Method	2	2
Biocompatibility	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	521	521
No Consequences Or Impact To Patient	57	57
Cardiac Perforation	44	44
Insufficient Information	39	39
No Known Impact Or Consequence To Patient	35	35
Exposure to Body Fluids	31	31
Cardiac Arrest	26	26
Cardiac Tamponade	24	24
Arrhythmia	19	19
Pericardial Effusion	11	11
Hemorrhage/Bleeding	9	9
Ventricular Fibrillation	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Perforation	8	8
Tachycardia	8	8
Heart Block	6	6
Asystole	6	6
Bradycardia	6	6
Unspecified Infection	5	5
No Information	4	4
Low Blood Pressure/ Hypotension	3	3
Failure of Implant	3	3
Atrial Fibrillation	3	3
Unspecified Tissue Injury	3	3
No Patient Involvement	3	3
Foreign Body In Patient	3	3
Device Embedded In Tissue or Plaque	2	2
Internal Organ Perforation	2	2
Aortic Valve Insufficiency/ Regurgitation	2	2
Loss of consciousness	2	2
Bacterial Infection	2	2
Myocardial Infarction	2	2
Perforation of Vessels	2	2
Vomiting	2	2
Septic Shock	2	2
Chest Pain	2	2
Needle Stick/Puncture	2	2
Multiple Organ Failure	2	2
Dizziness	2	2
Pneumothorax	2	2
Death	2	2
Stroke/CVA	2	2
Micturition Urgency	1	1
Thrombosis/Thrombus	1	1
Paralysis	1	1
Cardiopulmonary Arrest	1	1
Dyspnea	1	1
Laceration(s)	1	1
Pericarditis	1	1
Device Overstimulation of Tissue	1	1

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