Implantable Pulse Generator, Pacemaker (non-crt)

Device Code: 1012

Product Code(s): LWP

Definition: These Devices Treat Bradycardia (slow Heartbeats) With RA And/or RV Pacing Therapy As Necessary.

Device Classification Information

• Device Type ID: 1012
• Device Name: Implantable Pulse Generator, Pacemaker (non-crt)
• Physical State: These Devices Treat Bradycardia (slow Heartbeats) With RA And/or RV Pacing Therapy As Necessary.
• Technical Method: These Devices Treat Bradycardia (slow Heartbeats) With RA And/or RV Pacing Therapy As Necessary.
• Target Area: These Devices Treat Bradycardia (slow Heartbeats) With RA And/or RV Pacing 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: LWP
• 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
• 3-110 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: 1012
• Device: Implantable Pulse Generator, Pacemaker (non-crt)
• Product Code: LWP
• FDA Device Classification: Class 3 Medical Device

Device Problems
Device Displays Incorrect Message	7834
Premature Discharge Of Battery	7541
Adverse Event Without Identified Device Or Use Problem	7165
High Impedance	5319
Over-Sensing	3512
Ambient Noise Problem	3187
Failure To Capture	2644
Pacing Problem	2540
Device Operates Differently Than Expected	2384
Capturing Problem	2289
Material Integrity Problem	1929
Pacemaker Found In Back-Up Mode	1826
Device Dislodged Or Dislocated	1809
Device Alarm System	1608
Low Impedance	1139
Device Sensing Problem	1091
Connection Problem	825
Impedance Problem	515
Communication Or Transmission Problem	494
High Capture Threshold	479
Under-Sensing	470
Inappropriate Shock	431
Defective Device	419
Failure To Interrogate	383
Pocket Stimulation	382
Human-Device Interface Problem	380
Electrical /Electronic Property Problem	363
Fracture	344
Use Of Device Problem	339
Inappropriate Or Unexpected Reset	330
Operating System Version Or Upgrade Problem	313
Difficult To Position	290
Output Problem	261
Mechanical Problem	258
Appropriate Term/Code Not Available	234
Screw	228
Signal Artifact	210
No Device Output	194
No Display / Image	193
Data Problem	180
Defibrillation Problem	169
Noise, Audible	163
Positioning Problem	155
Telemetry Discrepancy	150
Migration Or Expulsion Of Device	147
Fitting Problem	140
Difficult To Remove	139
Premature Elective Replacement Indicator	129
Break	126
Power Problem	122
Failure To Sense	114
Reset Problem	107
Device Contamination With Chemical Or Other Material	90
Battery Problem	78
No Pacing	75
Device Contamination With Biological Material	70
Incorrect Measurement	67
Failure To Convert Rhythm	59
Loose Or Intermittent Connection	55
Misconnection	47
No Audible Alarm	45
Intermittent Capture	45
Programming Issue	41
Contamination During Use	40
Nonstandard Device	38
Wireless Communication Problem	38
Difficult To Interrogate	36
Pacing Inadequately	34
Failure To Power Up	33
Difficult To Insert	32
Lead	31
Insufficient Information	31
Unable To Obtain Readings	30
Battery Problem: High Impedance	30
Unstable Capture Threshold	30
Calibration Problem	29
Header	28
Interrogation Problem	26
Unexpected Shutdown	26
Missing Test Results	25
Problem With Software Installation	25
Degraded	25
Contamination / Decontamination Problem	23
Pacing Intermittently	22
Out-Of-Box Failure	21
Patient-Device Incompatibility	21
Product Quality Problem	21
Premature End-of-Life Indicator	19
Protective Measures Problem	18
Migration	17
Component Missing	17
Unexpected Therapeutic Results	16
Crack	16
Inadequate User Interface	15
Failure To Select Signal	15
Off-Label Use	15
Improper Alarm	14
Battery Impedance Issue	14
Application Program Version Or Upgrade Problem	14
Device Contamination With Body Fluid	12
Total Device Problems	65562

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific CRM Corp	II	Oct-18-2014
2	Boston Scientific Corporation	II	Jan-15-2018
3	Boston Scientific Corporation	II	Dec-30-2016
4	Boston Scientific Corporation	II	Sep-07-2016
5	Medtronic Inc. Cardiac Rhythm Disease Management	II	May-24-2014
6	St Jude Medical Inc.	II	Jun-12-2018

TPLC Last Update: 2019-04-02 19:46:24