Permanent Defibrillator Electrodes

Device Code: 1059

Product Code(s): NVY

Definition: Permanent Defibrillator Electrodes Are Used With Compatible Implantable Cardioverter Defibrillators (ICD) And Cardiac Rhythm Therapy-defibrillators (CRT-D) To Sense The Cardiac Rhythm And To Deliver High Energy Therapy To The Heart When Tachycardia I

Device Classification Information

• Device Type ID: 1059
• Device Name: Permanent Defibrillator Electrodes
• Physical State: The Device Is A Flexible, Insulated Electrical Conductor With One End Designed To Make A Secure Connection To An ICD Or CRT-D And The Other End Located In A Position Which Directs Defibrillation Energy To The Heart
• Technical Method: Used As Part Of An Implantable Defibrillation System.
• Target Area: Makes Contact With The Heart (endocardial Or Myocardial Tissue) Or Is Located In A Proximity And Orientation That Creates A Vector For Defibrillation Energy To The Heart.
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Implantable Electrophysical Devices Branch (IEDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: NVY
• GMP Exempt: No
• Summary MR: Ineligible
• 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
• 3-125 ISO 5841-3 Third Edition 2013-04-15
  Implants For Surgery - Cardiac Pacemakers - Part 3: Low-profile Connectors [IS-I] For Implantable Pacemakers
• 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: 1059
• Device: Permanent Defibrillator Electrodes
• Product Code: NVY
• FDA Device Classification: Class 3 Medical Device

Device Problems
Over-Sensing	5086
Adverse Event Without Identified Device Or Use Problem	4801
High Impedance	4028
Device Dislodged Or Dislocated	2848
Inappropriate Shock	2378
High Capture Threshold	2219
Signal Artifact	1891
Failure To Capture	1764
Ambient Noise Problem	1539
Break	1373
Low Impedance	1210
Fracture	1189
Device Sensing Problem	1035
Capturing Problem	928
Insulation	922
Impedance Problem	699
Decreased Sensitivity	501
Under-Sensing	477
Pacing Problem	399
Material Integrity Problem	377
Device Operates Differently Than Expected	328
Appropriate Term/Code Not Available	325
Positioning Failure	252
Human-Device Interface Problem	197
Intermittent Capture	169
Retraction Problem	168
Defibrillation Problem	158
Failure To Sense	155
Low Sensing Threshold	140
Insufficient Information	133
Helifix Coil	121
Activation, Positioning Or Separation Problem	102
Connection Problem	93
Unstable Capture Threshold	88
Difficult To Insert	82
Pocket Stimulation	82
Failure To Convert Rhythm	76
Positioning Problem	75
Difficult To Remove	75
Migration Or Expulsion Of Device	58
Defective Device	58
Difficult To Position	53
High Sensing Threshold	50
Stylet	48
Device Abrasion From Instrument Or Another Object	39
Output Problem	37
Nonstandard Device	33
Mechanical Problem	32
Electrical /Electronic Property Problem	29
Bent	28
Electromagnetic Interference	26
Screw	25
Device Contamination With Biological Material	24
Kinked	23
Failure To Deliver Shock	21
Fitting Problem	21
No Pacing	21
Material Twisted / Bent	21
Loose Or Intermittent Connection	20
Lead	17
Sensing Intermittently	17
Incorrect Interpretation Of Signal	16
Failure To Select Signal	16
Naturally Worn	16
Device Damaged By Another Device	15
Device Displays Incorrect Message	15
Therapeutic Or Diagnostic Output Failure	13
Loss Of Threshold	13
Use Of Device Problem	11
Electrical Lead	10
Material Deformation	10
Device Contamination With Chemical Or Other Material	9
Aborted Charge	9
Unexpected Therapeutic Results	9
Patient-Device Incompatibility	9
Defective Component	8
Collapse	8
Device Alarm System	8
Stretched	7
Pacing Inadequately	7
Failure To Interrogate	7
Difficult Or Delayed Positioning	7
Contamination / Decontamination Problem	6
Cut In Material	6
Premature Activation	5
Detachment Of Device Or Device Component	5
Malposition Of Device	5
Material Separation	5
Pacing Intermittently	5
Device-Device Incompatibility	4
Premature Elective Replacement Indicator	4
Connector Pin	4
Valve, Outlet Port	4
Device Damaged Prior To Use	4
Device Contamination With Body Fluid	4
Failure To Advance	4
Energy Output Problem	3
Migration	3
Invalid Sensing	3
Deformation Due To Compressive Stress	3
Total Device Problems	39484

TPLC Last Update: 2019-04-02 19:47:46