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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
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 9
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No code available 934
Mechanical issue 329
Loss of power 289
Connection issue 236
Failure to pace or properly pace 218
No display or display failure 209
Device displays error message 177
Failure to power-up 173
Not Applicable 104
Output issue 93
Device sensing issue 85
Electrical issue 84
Break 80
Crack 62
No device output 53
Power source issue 53
Defective item 51
No Information 49
Incorrect display 46
Failure to capture 42
Component missing 34
Failure to sense 33
Device inoperable 31
Nonstandard device or device component 25
Other (for use when an appropriate device code cannot be identified) 24
No Known Device Problem 24
Calibration issue 21
Failure of device to self-test 19
No pacing 19
Computer software issue 18
Use of Incorrect Control Settings 18
Defective component 17
Failure to shut off 17
Corrosion 15
Output energy incorrect 15
Undersensing 13
Oversensing 11
Device operates differently than expected 11
Low battery 10
Repair 8
Pacing intermittently 7
Device stops intermittently 7
Loose or intermittent connection 7
Contamination during use 7
Improper device output 7
Material integrity issue 7
Premature discharge of battery 5
Sensitivity 5
Pacing inadequately 5
Pacing asynchronously 4
Output above specifications 4
Output below specifications 4
Blocked connection 3
Foreign material present in device 3
Failure to fire 3
Malfunction 3
Detachment of device or device component 3
Moisture damage 3
Incorrect measurement 3
Degraded 3
Battery failure 3
Intermittent capture 3
Self-activation or keying 3
Difficult to Program or Calibrate 3
Out-of-box failure 3
Device contamination with blood or blood product 2
Inaccurate delivery 2
Device damaged prior to use 2
Inadequate service 2
Use of Device Issue 2
Program, failure to 2
Sensing intermittently 2
Incorrect software programming calculations 2
Disconnection 2
Overheating of device or device component 2
Artifact 2
Failure to run on AC/DC 2
Dislodged or dislocated 2
Failure to calibrate 2
Misfire 2
Inadequate user interface 2
Moisture or humidity problem 2
Operating system becomes non-functional 2
Programming issue 2
Protective measure issue 1
Reset issue 1
Scratched material 1
Data Issue 1
Noise, Audible 1
Positioning Issue 1
Measurement system incompatibility 1
Inappropriate or unexpected reset 1
Incompatibility problem 1
Human-Device Interface Issue 1
Improper alarm 1
Decreased sensitivity 1
High sensing threshold 1
Battery issue 1
Electrical power problem 1
Device or device component damaged by another device 1
Total Device Problems 3912

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-31-2015
2 Osypka Medical Inc II Sep-21-2010

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