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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulse-generator, pacemaker, external
Regulation Description External pacemaker pulse generator.
Product CodeDTE
Regulation Number 870.3600
Device Class 3


Premarket Reviews
ManufacturerDecision
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Connection Problem 1655
Mechanical Problem 391
No Display/Image 228
Calibration Problem 206
Device Displays Incorrect Message 171
Output Problem 156
Break 152
Display or Visual Feedback Problem 151
Electrical /Electronic Property Problem 113
No Device Output 101
Failure to Power Up 95
Component Missing 92
Device Sensing Problem 75
Use of Device Problem 60
Power Problem 54
Unexpected Shutdown 49
Material Integrity Problem 49
Failure to Sense 33
Device Operates Differently Than Expected 33
Loose or Intermittent Connection 33
Failure to Capture 32
Under-Sensing 28
Crack 26
Battery Problem 25
Nonstandard Device 25
Device Difficult to Program or Calibrate 20
Insufficient Information 20
Computer Software Problem 19
Contamination 19
Pacing Problem 18
Inadequate User Interface 17
Corroded 14
Degraded 14
Pacing Intermittently 14
Capturing Problem 13
Moisture Damage 12
Intermittent Capture 10
Difficult to Insert 9
Operating System Becomes Nonfunctional 9
Blocked Connection 9
Output below Specifications 9
Device Contamination with Chemical or Other Material 9
Failure to Shut Off 8
Contamination /Decontamination Problem 8
Signal Artifact/Noise 7
Output above Specifications 7
Data Problem 7
Over-Sensing 6
Electronic Property Issue 5
No Pacing 5
Sensing Intermittently 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2
Display Difficult to Read 2
Noise, Audible 2
Physical Resistance/Sticking 2
Detachment of Device or Device Component 2
Low Battery 2
Deformation Due to Compressive Stress 2
Premature Discharge of Battery 2
Application Program Freezes, Becomes Nonfunctional 2
Failure of Device to Self-Test 2
Device Dislodged or Dislocated 2
Impedance Problem 2
Failure to Calibrate 2
Computer Operating System Problem 2
Operating System Version or Upgrade Problem 1
Increased Sensitivity 1
Pacing Inadequately 1
Intermittent Loss of Power 1
Cut In Material 1
Device Handling Problem 1
Patient Device Interaction Problem 1
Positioning Problem 1
Component Misassembled 1
Detachment Of Device Component 1
Sticking 1
Reset Problem 1
Inadequate Lighting 1
Failure to Read Input Signal 1
Connector 1
Adverse Event Without Identified Device or Use Problem 1
Collapse 1
Patient-Device Incompatibility 1
Failure to Align 1
Scratched Material 1
Device Operational Issue 1
Device Difficult to Setup or Prepare 1
Incomplete or Inadequate Connection 1
Misfire 1
Fracture 1
Circuit Failure 1
Device Inoperable 1
Appropriate Term/Code Not Available 1
Total Device Problems 4380

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Detek, Inc. II Jul-03-2019
2 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-31-2015
3 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Jun-29-2018

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