Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes

Device Code: 1058

Product Code(s): NVN

Definition: Drug Eluting Permanent RV Or RA Pacemaker Electrodes Are Used With Compatible Pacemakers Or Implantable Cardioverter Defibrillators (ICD) Or Cardiac Rhythm Therapy (CRT) Devices To Deliver Pacing Pulses To The Heart.

Device Classification Information

• Device Type ID: 1058
• Device Name: Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
• Physical State: The Device Is A Flexible, Insulated Electrical Conductor With One End Designed To Make A Secure Connection To A Pacemaker Or ICD Or CRT And The Other End Applied To The Myocardium.
• Technical Method: Used As Part Of An Implantable Pacemaker System.
• Target Area: Makes Contact With The Heart (myocardial Tissue).
• 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: NVN
• 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
• 3-125 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: 1058
• Device: Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
• Product Code: NVN
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	5826
Device Dislodged Or Dislocated	5055
Over-Sensing	4634
High Capture Threshold	3781
Failure To Capture	3692
Signal Artifact	3675
High Impedance	2659
Low Impedance	1756
Break	1542
Material Integrity Problem	1525
Capturing Problem	1367
Fracture	1280
Device Sensing Problem	1106
Under-Sensing	1028
Ambient Noise Problem	1016
Insulation	974
Failure To Sense	713
Impedance Problem	679
Pacing Problem	666
Intermittent Capture	462
Insufficient Information	450
Device Operates Differently Than Expected	442
Difficult To Insert	306
Decreased Sensitivity	302
Appropriate Term/Code Not Available	300
Difficult To Position	277
Human-Device Interface Problem	274
Positioning Problem	263
Unstable Capture Threshold	249
Retraction Problem	200
Helifix Coil	155
Positioning Failure	146
Difficult To Remove	131
Defective Device	125
Stylet	124
No Pacing	110
Low Sensing Threshold	98
Pocket Stimulation	94
Activation, Positioning Or Separation Problem	89
Connection Problem	84
Electrical /Electronic Property Problem	74
Mechanical Problem	73
Device Abrasion From Instrument Or Another Object	67
Bent	61
Material Twisted / Bent	56
Electrical Lead	51
High Sensing Threshold	50
Electronic Property Issue	48
Device Contamination With Biological Material	48
Screw	47
Inappropriate Shock	38
Sensing Intermittently	37
Failure To Select Signal	37
Use Of Device Problem	34
Patient-Device Incompatibility	31
Pacing Intermittently	31
Kinked	30
Lead	27
Loose Or Intermittent Connection	25
Device Damaged By Another Device	24
Guidewire	24
Invalid Sensing	23
Stretched	22
Degraded	21
Pacing Inadequately	21
Electromagnetic Interference	20
Device-Device Incompatibility	20
Migration Or Expulsion Of Device	18
Defective Component	17
Device Contamination With Body Fluid	17
Device Contamination With Chemical Or Other Material	16
Material Deformation	16
Collapse	16
Malposition Of Device	14
Structural Problem	14
Difficult Or Delayed Positioning	14
Product Quality Problem	13
Difficult To Advance	13
Fitting Problem	13
Separation Failure	12
Cut In Material	12
Output Problem	10
Device Handling Problem	10
Accessory Incompatible	9
Loss Of Threshold	9
Naturally Worn	9
Detachment Of Device Or Device Component	8
Detachment Of Device Component	8
Migration	8
Failure To Advance	7
Device Expiration Issue	7
Connector Pin	7
Material Separation	6
Pin	6
Contamination / Decontamination Problem	6
Deformation Due To Compressive Stress	6
Misconnection	5
Incorrect Interpretation Of Signal	5
Off-Label Use	4
Lead Tip	4
Total Device Problems	49034

TPLC Last Update: 2019-04-02 19:47:44