Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)

Device Code: 1053

Product Code(s): NKE

Definition: These Devices Are Indicated For Patients Who Have Moderate To Severe Heart Failure. These New Devices Use An Additional Lead To Provide Synchronized Pacing Of The Heart, In Addition To The Regular Features Of A Pacemaker. These Products Are Sought Fo

Device Classification Information

• Device Type ID: 1053
• Device Name: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
• Physical State: These Devices Are Indicated For Patients Who Have Moderate To Severe Heart Failure. These New Devices Use An Additional Lead To Provide Synchronized Pacing Of The Heart, In Addition To The Regular Features Of A Pacemaker. These Products Are Sought Fo
• Technical Method: These Devices Are Indicated For Patients Who Have Moderate To Severe Heart Failure. These New Devices Use An Additional Lead To Provide Synchronized Pacing Of The Heart, In Addition To The Regular Features Of A Pacemaker. These Products Are Sought Fo
• Target Area: These Devices Are Indicated For Patients Who Have Moderate To Severe Heart Failure. These New Devices Use An Additional Lead To Provide Synchronized Pacing Of The Heart, In Addition To The Regular Features Of A Pacemaker. These Products Are Sought Fo
• 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: NKE
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: Yes
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-110 AAMI TIR 41:2011/(R)2017
  Technical Information Report Active Implantable Medical Devices - Guidance For Designation Of Left Ventricle And Implantable Cardioverter Defibrillator Lead Connectors And Pulse Generator Connector Cavities For Implantable Pacemakers And Implantable Cardioverter Defibrillators
• 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
• 3-139 ISO 14117 First Edition 2012-07-15
  Active Implantable Medical Devices -- Electromagnetic Compatibility -- EMC Test Protocols For Implantable Cardiac Pacemakers, Implantable Cardioverter Defibrillators, And Cardiac Resynchronization Devices

Total Product Life Cycle

• Device Type ID: 1053
• Device: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
• Product Code: NKE
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	641
Over-Sensing	220
High Impedance	214
Ambient Noise Problem	150
Inappropriate Or Unexpected Reset	149
Pacing Problem	144
Pacemaker Found In Back-Up Mode	137
Device Operates Differently Than Expected	100
Reset Problem	98
Failure To Capture	79
Premature Discharge Of Battery	77
Use Of Device Problem	55
Device Sensing Problem	46
Unable To Obtain Readings	44
Capturing Problem	41
Device Displays Incorrect Message	38
Mechanical Problem	37
Operating System Version Or Upgrade Problem	33
Low Impedance	32
Failure To Interrogate	31
Connection Problem	27
Incorrect Measurement	23
Impedance Problem	22
Signal Artifact	20
Data Problem	20
Communication Or Transmission Problem	20
Pocket Stimulation	18
Screw	17
Appropriate Term/Code Not Available	15
Telemetry Discrepancy	15
High Capture Threshold	15
Under-Sensing	14
Premature Elective Replacement Indicator	12
Output Problem	12
Misconnection	12
Difficult To Interrogate	11
Migration Or Expulsion Of Device	9
Defective Device	9
No Device Output	7
Electrical /Electronic Property Problem	7
No Pacing	6
Difficult To Remove	6
Fitting Problem	6
Lead	5
Battery Problem	5
Material Integrity Problem	4
Pacing Inadequately	4
Header	4
Device Difficult To Program Or Calibrate	3
Failure To Sense	3
Problem With Software Installation	3
Intermittent Capture	3
Difficult To Insert	3
Loose Or Intermittent Connection	3
Device Contamination With Biological Material	3
Out-Of-Box Failure	3
Protective Measures Problem	3
Electromagnetic Interference	2
Pacing Intermittently	2
Off-Label Use	2
Failure To Disconnect	2
Device Alarm System	2
Break	2
Insufficient Information	2
Programming Issue	2
Application Program Version Or Upgrade Problem	2
Loss Of Data	2
Contamination During Use	1
Device Contamination With Body Fluid	1
Unintended Electrical Shock	1
Human-Device Interface Problem	1
Inadequate Service	1
Output Above Specifications	1
Material Frayed	1
Circuit Failure	1
Display Or Visual Feedback Problem	1
Labelling, Instructions For Use Or Training Problem	1
Battery Problem: Low Impedance	1
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Shelf Life Exceeded	1
Low Sensing Threshold	1
Low Battery	1
Defibrillation Problem	1
Premature End-of-Life Indicator	1
Incorrect Interpretation Of Signal	1
Wireless Communication Problem	1
Failure To Convert Rhythm	1
Total Device Problems	2778

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jan-15-2018
2	Medtronic Inc.	II	Nov-27-2015
3	Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)	II	Jul-10-2018
4	St Jude Medical Inc.	II	Jun-12-2018

TPLC Last Update: 2019-04-02 19:47:36