Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode

Device Code: 1070

Product Code(s): OJX

Definition: Drug Eluting Permanent Lv Pacemaker Electrodes Are Used With Compatible Cardiac Rhythm Therapy (crt) Devices To Deliver Pacing Pulses To The Heart.

Device Classification Information

• Device Type ID: 1070
• Device Name: Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
• Physical State: The Device Is A Flexible, Insulated Electrical Conductor With One End Designed To Make A Secure Connection To A CRT Device And The Other End Located In A Left Cardiac Vein.
• Technical Method: Used As Part Of An Implantable Crt System.
• Target Area: Makes Contact With The Lv Via The Left Cardiac Vein.
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Cardiac Diagnostics Devices Branch (CDDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: OJX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-89 ISO 27186 First Edition 2010-03-15
  Active Implantable Medical Devices - Four-pole Connector System For Implantable Cardiac Rhythm Management Devices - Dimensional And Test Requirements
• 3-132 ISO 27185 First Edition 2012-02-15
  Cardiac Rhythm Management Devices - Symbols To Be Used With Cardiac Rhythm Management Device Labels, And Information To Be Supplied - General Requirements
• 3-143 ISO 12417 First Edition 2015-10-01
  Cardiovascular Implants And Extracorporeal Systems - Vascular Device-drug Combination Products

Total Product Life Cycle

• Device Type ID: 1070
• Device: Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
• Product Code: OJX
• FDA Device Classification: Class 3 Medical Device

Device Problems
Device Dislodged Or Dislocated	2427
Adverse Event Without Identified Device Or Use Problem	2161
High Capture Threshold	1590
Failure To Capture	1356
Appropriate Term/Code Not Available	719
High Impedance	626
Activation, Positioning Or Separation Problem	458
Capturing Problem	381
Positioning Problem	268
Break	259
Difficult To Insert	213
Fracture	203
Difficult To Remove	200
Low Impedance	180
Impedance Problem	150
Guidewire	130
Intermittent Capture	94
Unstable Capture Threshold	83
Over-Sensing	76
Insulation	76
Stylet	68
Pacing Problem	63
Device Operates Differently Than Expected	62
Signal Artifact	60
Material Integrity Problem	52
Separation Failure	38
Insufficient Information	34
Difficult To Position	33
Device Sensing Problem	33
Failure To Sense	30
Connection Problem	30
Pocket Stimulation	25
Mechanical Problem	23
No Pacing	21
Ambient Noise Problem	20
Positioning Failure	20
Device Handling Problem	19
Electrical /Electronic Property Problem	17
Device Contamination With Body Fluid	17
Accessory Incompatible	15
High Sensing Threshold	13
Under-Sensing	11
Difficult To Advance	11
Malposition Of Device	10
Bent	10
Retraction Problem	10
Pacing Inadequately	9
Device Damaged By Another Device	9
Detachment Of Device Component	9
Suture	8
Inappropriate Shock	8
Difficult Or Delayed Positioning	8
Improper Or Incorrect Procedure Or Method	7
Failure To Advance	7
Kinked	7
Loose Or Intermittent Connection	7
Defective Device	7
Lead	6
Material Deformation	6
Catheter	6
Programming Issue	5
Migration Or Expulsion Of Device	5
Connector Pin	5
Cut In Material	5
Shelf Life Exceeded	4
Stretched	4
Collapse	4
Low Sensing Threshold	4
Device Contamination With Chemical Or Other Material	4
Loss Of Threshold	4
Material Separation	4
Material Twisted / Bent	4
Misconnection	4
No Apparent Adverse Event	4
Structural Problem	4
Difficult To Flush	4
Electronic Property Issue	3
Physical Resistance / Sticking	3
Flushing Problem	3
Detachment Of Device Or Device Component	3
No Device Output	2
Helifix Coil	2
Material Perforation	2
Defibrillation Problem	2
Device Damaged Prior To Use	2
Device Markings / Labelling Problem	2
Manufacturing, Packaging Or Shipping Problem	2
Entrapment Of Device	2
Device-Device Incompatibility	2
Sensing Intermittently	2
Electromagnetic Interference	2
Material Fragmentation	2
Pacing Intermittently	2
Product Quality Problem	2
Migration	2
Human-Device Interface Problem	2
Device Abrasion From Instrument Or Another Object	2
Degraded	2
Deformation Due To Compressive Stress	2
Use Of Device Problem	2
Total Device Problems	12619

TPLC Last Update: 2019-04-02 19:47:57