Pulse Generator, Permanent, Implantable

Device Code: 1060

Product Code(s): NVZ

Definition: Intended As A Permanent Implant To Deliver Pacing Pulses And Other Pacing Therapies Through Pacing Leads Implanted In The Heart.

Device Classification Information

• Device Type ID: 1060
• Device Name: Pulse Generator, Permanent, Implantable
• Physical State: A Hermetically Sealed Outer Can (usually Metallic) Houses Electronic Circuitry And Allows For Connection To Pacing Leads (electrodes).
• Technical Method: Used As Part Of A Pacing System That Consists Of A Pulse Generator And A Lead, And Which May Also Require An External Pacemaker Programmer.
• Target Area: Implanted In The Chest Or Abdomen, And Makes Contact With Cardiac Tissue Via Pacing Leads.
• 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: NVZ
• 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

Total Product Life Cycle

• Device Type ID: 1060
• Device: Pulse Generator, Permanent, Implantable
• Product Code: NVZ
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	2269
Battery Problem	1852
Premature Discharge Of Battery	1827
Pacing Problem	1261
Mechanical Problem	782
Over-Sensing	719
Appropriate Term/Code Not Available	707
Failure To Interrogate	585
Failure To Capture	326
Inappropriate Or Unexpected Reset	297
Unable To Obtain Readings	295
Incorrect Measurement	283
High Impedance	234
Pacemaker Found In Back-Up Mode	188
Communication Or Transmission Problem	186
Inappropriate Shock	166
Device Operates Differently Than Expected	160
Device Sensing Problem	159
Migration Or Expulsion Of Device	153
Premature Elective Replacement Indicator	152
Under-Sensing	125
Signal Artifact	119
Reset Problem	115
Output Problem	109
Overheating Of Device	103
High Capture Threshold	103
Capturing Problem	97
Battery Problem: High Impedance	92
Device Displays Incorrect Message	91
Misconnection	91
Data Problem	87
No Pacing	83
Insufficient Information	82
Impedance Problem	68
Break	64
Use Of Device Problem	63
False Positive Result	53
Low Impedance	52
Delayed Charge Time	51
Incorrect Interpretation Of Signal	45
Connection Problem	43
Electrical /Electronic Property Problem	39
Nonstandard Device	38
Intermittent Capture	37
Electromagnetic Interference	37
Battery Impedance Issue	36
Premature End-of-Life Indicator	32
Loose Or Intermittent Connection	31
Invalid Sensing	30
Telemetry Discrepancy	29
Pacing Inadequately	28
Protective Measures Problem	27
Missing Test Results	24
Screw	24
Difficult To Interrogate	23
Defibrillation Problem	23
Ambient Noise Problem	23
Failure To Deliver Shock	23
Loss Of Data	20
Failure To Charge	19
Device Emits Odor	18
Device-Device Incompatibility	18
Pocket Stimulation	17
Failure To Sense	17
False Alarm	16
Output Above Specifications	16
Pacing Intermittently	16
Display Or Visual Feedback Problem	16
Unstable Capture Threshold	15
Decreased Sensitivity	15
Component Missing	15
Incorrect, Inadequate Or Imprecise Result Or Readings	14
Positioning Problem	14
Incorrect Or Inadequate Test Results	13
Power Problem	13
Device Contamination With Body Fluid	12
Device Expiration Issue	12
Defective Alarm	10
Wireless Communication Problem	10
Programming Issue	10
Device Dislodged Or Dislocated	10
Failure To Transmit Record	10
Device Contamination With Chemical Or Other Material	9
Incorrect Device Or Component Shipped	9
Fitting Problem	9
Low Battery	8
No Device Output	8
Defective Device	7
Header	7
Application Program Version Or Upgrade Problem	6
Cap	6
Material Integrity Problem	6
Energy Output Problem	6
Lead	6
Device Alarm System	6
Device Damaged By Another Device	6
Device Packaging Compromised	6
Failure To Convert Rhythm	5
Material Erosion	5
Noise, Audible	5
Total Device Problems	15307

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc., Cardiac Rhythm And Heart Failure	II	Jan-19-2018
2	Medtronic Inc., Cardiac Rhythm And Heart Failure	II	Jul-05-2016
3	Medtronic Inc., Cardiac Rhythm And Heart Failure	II	May-04-2016
4	Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF)	I	Feb-14-2019
5	St Jude Medical Cardiac Rhythm Management Division	II	Sep-28-2015
6	St Jude Medical Cardiac Rhythm Management Division	II	Jan-09-2015

TPLC Last Update: 2019-04-02 19:47:48