Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)

Device Code: 1045

Product Code(s): NIK

Definition: These Devices Will Be Indicated For Patients Needing An ICD Who Also Have Moderate To Severe Heart Failure And Are Indicated For Cardiac Resynchronization Therapy.

Device Classification Information

• Device Type ID: 1045
• Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
• Physical State: These Devices Will Be Indicated For Patients Needing An ICD Who Also Have Moderate To Severe Heart Failure And Are Indicated For Cardiac Resynchronization Therapy.
• Technical Method: These Devices Will Be Indicated For Patients Needing An ICD Who Also Have Moderate To Severe Heart Failure And Are Indicated For Cardiac Resynchronization Therapy.
• Target Area: These Devices Will Be Indicated For Patients Needing An ICD Who Also Have Moderate To Severe Heart Failure And Are Indicated For Cardiac Resynchronization Therapy.
• 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: NIK
• 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: 1045
• Device: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
• Product Code: NIK
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	6449
Over-Sensing	5335
Premature Discharge Of Battery	3554
High Impedance	1529
Inappropriate Shock	1197
Battery Problem	1175
Failure To Capture	812
Inappropriate Or Unexpected Reset	763
Pacing Problem	675
Device Operates Differently Than Expected	594
Mechanical Problem	546
Failure To Interrogate	467
Electrical /Electronic Property Problem	464
Device Dislodged Or Dislocated	451
Ambient Noise Problem	443
Capturing Problem	410
Invalid Sensing	410
Device Sensing Problem	303
Device Displays Incorrect Message	297
Signal Artifact	269
Under-Sensing	262
Connection Problem	239
High Capture Threshold	231
Low Impedance	228
Fracture	228
Defibrillation Problem	225
Communication Or Transmission Problem	193
Misconnection	172
Impedance Problem	166
Appropriate Term/Code Not Available	153
Delayed Charge Time	144
Material Integrity Problem	139
Premature Elective Replacement Indicator	134
Device Alarm System	115
Migration Or Expulsion Of Device	99
Pocket Stimulation	92
Screw	92
Output Problem	91
Data Problem	90
Pacemaker Found In Back-Up Mode	81
Incorrect Interpretation Of Signal	78
Difficult To Remove	77
Insufficient Information	76
Premature End-of-Life Indicator	76
Use Of Device Problem	73
Electromagnetic Interference	70
Unable To Obtain Readings	66
Protective Measures Problem	62
Incorrect Measurement	59
Failure To Convert Rhythm	57
Defective Device	52
Failure To Charge	52
Difficult To Insert	50
No Pacing	49
Telemetry Discrepancy	44
Intermittent Capture	43
Fitting Problem	42
Reset Problem	37
Difficult To Interrogate	37
Break	36
Loose Or Intermittent Connection	34
Failure To Sense	33
Programming Issue	32
Failure To Deliver Shock	32
Header	30
Wireless Communication Problem	28
Decreased Sensitivity	27
No Apparent Adverse Event	25
Guidewire	24
Therapeutic Or Diagnostic Output Failure	23
Insulation	22
No Device Output	20
Pacing Inadequately	19
Nonstandard Device	17
Unexpected Therapeutic Results	16
Vibration	15
Component Missing	15
Stylet	15
Application Program Version Or Upgrade Problem	14
Difficult To Position	13
Incorrect, Inadequate Or Imprecise Result Or Readings	13
Human-Device Interface Problem	12
Migration	11
Difficult To Advance	11
Defective Alarm	10
Noise, Audible	10
Separation Failure	10
Sensing Intermittently	10
False Alarm	10
Retraction Problem	10
Device Contamination With Biological Material	9
Unstable Capture Threshold	9
Low Battery	8
Lead	8
Contamination / Decontamination Problem	8
Missing Test Results	8
Patient-Device Incompatibility	7
Device Contamination With Body Fluid	7
No Audible Alarm	7
Device Expiration Issue	7
Total Device Problems	31092

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Nov-08-2017
2	Medtronic Inc., Cardiac Rhythm And Heart Failure	II	May-19-2017
3	Medtronic Inc., Cardiac Rhythm And Heart Failure	II	Jan-07-2017
4	Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)	I	Feb-01-2018
5	Sorin CRM SAS	II	Aug-15-2018
6	Sorin Group Italia SRL - CRF	II	Sep-28-2017
7	St Jude Medical Inc.	II	Jun-29-2018
8	St Jude Medical Inc.	II	Jun-12-2018
9	St Jude Medical Inc.	I	Oct-10-2017
10	St Jude Medical Inc.	I	Oct-21-2016

TPLC Last Update: 2019-04-02 19:47:21