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 ID1060
Device NamePulse Generator, Permanent, Implantable
Physical StateA Hermetically Sealed Outer Can (usually Metallic) Houses Electronic Circuitry And Allows For Connection To Pacing Leads (electrodes).
Technical MethodUsed 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 AreaImplanted In The Chest Or Abdomen, And Makes Contact With Cardiac Tissue Via Pacing Leads.
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeNVZ
GMP ExemptNo
Summary MRIneligible
Implanted DeviceYes
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1060
DevicePulse Generator, Permanent, Implantable
Product CodeNVZ
FDA Device ClassificationClass 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

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