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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 7
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 293
Loss of power 289
Failure to pace or properly pace 216
No display or display failure 194
Failure to power-up 163
Device displays error message 127
Not Applicable 104
Output issue 80
Device sensing issue 80
Electrical issue 73
Connection issue 68
Break 65
Crack 61
Defective item 51
No Information 48
Incorrect display 46
Power source issue 44
Failure to capture 42
No device output 39
Device inoperable 30
Failure to sense 29
Component missing 27
Nonstandard device or device component 25
Other (for use when an appropriate device code cannot be identified) 24
No Known Device Problem 24
Failure of device to self-test 19
No pacing 18
Computer software issue 18
Use of Incorrect Control Settings 18
Defective component 17
Failure to shut off 16
Output energy incorrect 15
Corrosion 11
Oversensing 11
Undersensing 10
Device operates differently than expected 10
Low battery 9
Repair 8
Device stops intermittently 7
Pacing intermittently 7
Improper device output 7
Contamination during use 6
Loose or intermittent connection 6
Premature discharge of battery 5
Pacing inadequately 5
Sensitivity 5
Calibration issue 5
Pacing asynchronously 4
Output above specifications 4
Incorrect measurement 3
Battery failure 3
Intermittent capture 3
Difficult to Program or Calibrate 3
Self-activation or keying 3
Malfunction 3
Out-of-box failure 3
Detachment of device or device component 3
Failure to fire 3
Output below specifications 3
Programming issue 2
Blocked connection 2
Moisture or humidity problem 2
Device damaged prior to use 2
Use of Device Issue 2
Failure to calibrate 2
Misfire 2
Device contamination with blood or blood product 2
Inaccurate delivery 2
Sensing intermittently 2
Inadequate service 2
Program, failure to 2
Incorrect software programming calculations 2
Failure to run on AC/DC 2
Disconnection 2
Overheating of device or device component 2
Pacer found in back-up mode 1
Moisture damage 1
Fracture 1
Function indicator light(s), failure of 1
Image display error 1
Insulation degradation 1
Degraded 1
Material discolored 1
Connection error 1
Alarm, failure of warning 1
Artifact 1
Bent 1
Blank screen 1
Cable break 1
Calibration error 1
Device remains activated 1
Failure to run on portable mode 1
Inappropriate shock 1
Device Issue 1
Decreased sensitivity 1
High sensing threshold 1
Unknown (for use when the device problem is not known) 1
Incomplete or missing packaging 1
Noise, Audible 1
Total Device Problems 3503

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