Permanent Pacemaker Electrode

Device Code: 780

Product Code(s): DTB

Device Classification Information

• Device Type ID: 780
• Device Name: Permanent Pacemaker Electrode
• Regulation Description: Cardiovascular Permanent Or Temporary Pacemaker Electrode.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Implantable Electrophysical Devices Branch (IEDB)
• Submission Type: PMA
• CFR Regulation Number: 870.3680 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: DTB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-125 ISO 5841-3 Third Edition 2013-04-15
  Implants For Surgery - Cardiac Pacemakers - Part 3: Low-profile Connectors [IS-I] For Implantable Pacemakers
• 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: 780
• Device: Permanent Pacemaker Electrode
• Product Code: DTB
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Cardiovascular Permanent Or Temporary Pacemaker Electrode.
• CFR Regulation Number: 870.3680 [🔎]

Device Problems
High Capture Threshold	7301
Over-Sensing	6371
Device Dislodged Or Dislocated	6016
High Impedance	5497
Under-Sensing	5446
Adverse Event Without Identified Device Or Use Problem	5419
Failure To Capture	4619
Fracture	2949
Capturing Problem	2913
Signal Artifact	2176
Low Impedance	2151
Impedance Problem	1957
Pacing Problem	1595
Positioning Problem	1378
Activation, Positioning Or Separation Problem	1366
Material Integrity Problem	1165
Ambient Noise Problem	1133
Unstable Capture Threshold	1061
Decreased Sensitivity	1037
Device Sensing Problem	1013
Break	949
Appropriate Term/Code Not Available	841
Failure To Sense	743
Positioning Failure	717
Device Operates Differently Than Expected	678
Intermittent Capture	667
Electronic Property Issue	420
Connection Problem	284
Electrical /Electronic Property Problem	270
Pocket Stimulation	215
Insufficient Information	213
Mechanical Problem	182
Bent	165
Difficult To Remove	163
Degraded	127
Human-Device Interface Problem	123
Defective Device	119
Collapse	104
Premature Activation	100
Inappropriate Shock	69
Insulation	67
Difficult To Position	65
Device-Device Incompatibility	63
High Sensing Threshold	54
Electromagnetic Interference	50
Material Twisted / Bent	44
Device Contamination With Body Fluid	41
Material Deformation	38
Stretched	38
Cut In Material	37
Kinked	37
Device Handling Problem	36
Use Of Device Problem	35
No Pacing	31
Difficult To Advance	31
Loose Or Intermittent Connection	27
Difficult To Insert	26
Device Contamination With Biological Material	26
Crack	25
Stylet	22
Explanted	21
Sensing Intermittently	20
Material Separation	19
Device Displays Incorrect Message	19
Failure To Interrogate	19
Migration Or Expulsion Of Device	19
Communication Or Transmission Problem	18
Retraction Problem	18
Material Split, Cut Or Torn	17
Premature Discharge Of Battery	16
Device Contamination With Chemical Or Other Material	16
Pacemaker Found In Back-Up Mode	16
Device Expiration Issue	14
Packaging Problem	14
Manufacturing, Packaging Or Shipping Problem	14
Patient-Device Incompatibility	14
Difficult Or Delayed Positioning	13
Contamination / Decontamination Problem	12
Failure To Advance	12
Shelf Life Exceeded	12
Helifix Coil	12
Detachment Of Device Component	12
Display Or Visual Feedback Problem	11
Disconnection	11
Failure To Select Signal	10
Fitting Problem	10
Pacing Inadequately	10
Invalid Sensing	9
No Apparent Adverse Event	9
Component Missing	9
Screw	9
Detachment Of Device Or Device Component	9
Naturally Worn	8
Accessory Incompatible	8
Pacing Intermittently	8
Wireless Communication Problem	8
Delivered As Unsterile Product	8
Expiration Date Error	8
Corroded	8
Device Contaminated During Manufacture Or Shipping	7
Total Device Problems	71012

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc. Cardiac Rhythm Disease Management	II	Oct-05-2015

TPLC Last Update: 2019-04-02 19:41:23