Implantable Cardioverter Defibrillator (non-crt)

Device Code: 1015

Product Code(s): LWS

Definition: These Devices Treat Tachycardia (fast Heartbeats) With RV Defibrillation Therapy As Necessary.

Device Classification Information

• Device Type ID: 1015
• Device Name: Implantable Cardioverter Defibrillator (non-crt)
• Physical State: These Devices Treat Tachycardia (fast Heartbeats) With RV Defibrillation Therapy As Necessary.
• Technical Method: These Devices Treat Tachycardia (fast Heartbeats) With RV Defibrillation Therapy As Necessary.
• Target Area: These Devices Treat Tachycardia (fast Heartbeats) With RV Defibrillation Therapy As Necessary.
• 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: LWS
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: Yes
• Life Support Device: Yes
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-63 ISO 11318:2002
  Cardiac Defibrillators -- Connector Assembly DF-1 For Implantable Defibrillators - Dimensions And Test Requirements.
• 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
• 3-110 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
• 12-268 IEC 60601-2-22 Edition 3.1 2012-10
  Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment

Total Product Life Cycle

• Device Type ID: 1015
• Device: Implantable Cardioverter Defibrillator (non-crt)
• Product Code: LWS
• FDA Device Classification: Class 3 Medical Device

Device Problems
Over-Sensing	12020
High Impedance	9625
Adverse Event Without Identified Device Or Use Problem	8158
Inappropriate Shock	5433
Fracture	4087
Signal Artifact	3725
Premature Discharge Of Battery	3375
Device Displays Incorrect Message	2914
Impedance Problem	2719
High Capture Threshold	2317
Ambient Noise Problem	2181
Device Sensing Problem	1731
Battery Problem	1694
Device Operates Differently Than Expected	1664
Capturing Problem	1473
Low Impedance	1439
Pacing Problem	1343
Failure To Capture	1320
Under-Sensing	1262
Device Dislodged Or Dislocated	1144
Inappropriate Or Unexpected Reset	945
Invalid Sensing	813
Device Alarm System	795
Failure To Interrogate	733
Appropriate Term/Code Not Available	671
Mechanical Problem	668
Defibrillation Problem	655
Decreased Sensitivity	646
Material Integrity Problem	622
Positioning Failure	613
Connection Problem	610
Break	596
Communication Or Transmission Problem	564
Electrical /Electronic Property Problem	557
Delayed Charge Time	449
Activation, Positioning Or Separation Problem	445
Failure To Convert Rhythm	417
Positioning Problem	300
Premature Elective Replacement Indicator	260
Migration Or Expulsion Of Device	248
Defective Device	231
Unstable Capture Threshold	228
Insufficient Information	192
Electromagnetic Interference	175
Protective Measures Problem	169
Output Problem	156
Failure To Charge	156
Reset Problem	143
Nonstandard Device	140
Difficult To Remove	140
Screw	120
Human-Device Interface Problem	117
Premature End-of-Life Indicator	117
Misconnection	113
Unable To Obtain Readings	112
Intermittent Capture	111
Loose Or Intermittent Connection	110
Data Problem	110
Pacemaker Found In Back-Up Mode	108
Failure To Sense	104
Insulation	103
Incorrect Measurement	95
Incorrect Interpretation Of Signal	81
Telemetry Discrepancy	72
Failure To Select Signal	70
Fitting Problem	60
Pocket Stimulation	59
Collapse	53
Device-Device Incompatibility	51
Programming Issue	49
Use Of Device Problem	47
Difficult To Interrogate	46
Bent	42
Patient-Device Incompatibility	41
No Audible Alarm	40
Header	40
Charging Problem	35
Device Contamination With Body Fluid	35
Interrogation Problem	34
Therapeutic Or Diagnostic Output Failure	33
Wireless Communication Problem	33
Difficult To Insert	33
Unexpected Therapeutic Results	31
Failure To Deliver Shock	30
Device Contamination With Biological Material	29
Material Deformation	28
False Alarm	28
Migration	28
Noise, Audible	25
Aborted Charge	22
Improper Alarm	22
No Pacing	22
Difficult To Position	21
Stretched	20
No Device Output	19
Low Sensing Threshold	17
Device Contamination With Chemical Or Other Material	17
Missing Test Results	17
Premature Activation	16
Device Expiration Issue	15
Total Device Problems	85642

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific CRM Corp	II	Aug-05-2014
2	Boston Scientific Corporation	II	Nov-16-2018
3	Boston Scientific Corporation	II	Sep-27-2018
4	Boston Scientific Corporation	II	Sep-27-2018
5	Boston Scientific Corporation	II	Nov-08-2017
6	Boston Scientific Corporation	II	Aug-16-2017
7	Boston Scientific Corporation	II	Feb-09-2017
8	Boston Scientific Corporation	II	Nov-06-2015
9	Medtronic Inc., Cardiac Rhythm And Heart Failure	II	Aug-25-2016
10	Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)	II	Jul-10-2018
11	Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)	I	Feb-01-2018
12	St Jude Medical Cardiac Rhythm Management Division	I	Jan-21-2016
13	St Jude Medical Cardiac Rhythm Management Division	II	Sep-03-2014
14	St Jude Medical Inc.	II	Jun-29-2018
15	St Jude Medical Inc.	I	Oct-10-2017
16	St Jude Medical Inc.	I	Oct-21-2016
17	St Jude Medical Inc.	II	May-10-2016

TPLC Last Update: 2019-04-02 19:46:36