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
C. R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC INC
	SUBSTANTIALLY EQUIVALENT	1
1. K242705 Streamline Unipolar Pediatric Temporary Pacing Lea ...
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	202	202
Break	101	101
Inflation Problem	60	60
Adverse Event Without Identified Device or Use Problem	53	53
No Pacing	52	52
Material Separation	50	50
Material Integrity Problem	25	25
Fracture	20	20
Detachment of Device or Device Component	19	19
Deformation Due to Compressive Stress	19	19
Insufficient Information	17	17
Patient Device Interaction Problem	16	16
Burst Container or Vessel	15	15
Material Frayed	11	11
Material Puncture/Hole	11	11
Material Rupture	10	10
Material Too Rigid or Stiff	10	10
Connection Problem	10	10
Device Dislodged or Dislocated	9	9
Gas/Air Leak	9	9
Failure to Sense	9	9
Failure to Infuse	8	8
Failure to Capture	8	8
Material Twisted/Bent	8	8
Material Split, Cut or Torn	7	7
Accessory Incompatible	7	7
Device Sensing Problem	6	6
Disconnection	5	5
Loss of Threshold	5	5
Difficult to Remove	5	5
Fluid/Blood Leak	5	5
Material Fragmentation	5	5
Positioning Failure	5	5
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Difficult to Advance	4	4
Material Deformation	4	4
Device Markings/Labelling Problem	4	4
Component Misassembled	3	3
Nonstandard Device	3	3
Pacing Inadequately	3	3
Material Protrusion/Extrusion	2	2
Biocompatibility	2	2
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	2	2
Difficult or Delayed Separation	2	2
Unstable Capture Threshold	2	2
Communication or Transmission Problem	2	2
Physical Resistance/Sticking	2	2
Device Damaged Prior to Use	2	2
Decrease in Pressure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	531	531
No Consequences Or Impact To Patient	57	57
Cardiac Perforation	44	44
Insufficient Information	40	40
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
Unspecified Infection	6	6
Heart Block	6	6
Asystole	6	6
Bradycardia	6	6
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