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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 308
Loss of power 289
Failure to pace or properly pace 218
No display or display failure 203
Failure to power-up 169
Device displays error message 153
Connection issue 129
Not Applicable 104
Output issue 83
Device sensing issue 81
Electrical issue 81
Break 72
Crack 61
Defective item 51
No Information 49
No device output 49
Power source issue 48
Incorrect display 46
Failure to capture 42
Failure to sense 33
Component missing 32
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
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 14
Calibration issue 14
Undersensing 11
Oversensing 11
Device operates differently than expected 10
Low battery 10
Repair 8
Loose or intermittent connection 8
Pacing intermittently 7
Device stops intermittently 7
Improper device output 7
Contamination during use 6
Premature discharge of battery 5
Sensitivity 5
Pacing inadequately 5
Pacing asynchronously 4
Output above specifications 4
Incorrect measurement 3
Battery failure 3
Intermittent capture 3
Self-activation or keying 3
Difficult to Program or Calibrate 3
Out-of-box failure 3
Foreign material present in device 3
Material integrity issue 3
Failure to fire 3
Malfunction 3
Detachment of device or device component 3
Output below specifications 3
Programming issue 2
Failure to calibrate 2
Misfire 2
Blocked connection 2
Moisture or humidity problem 2
Inadequate user interface 2
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
Alarm, failure of warning 1
Bent 1
Blank screen 1
Cable break 1
Calibration error 1
Connection error 1
Collapse 1
Moisture damage 1
Application interface becomes non-functional or program exits abnormally 1
Degraded 1
Material discolored 1
Fracture 1
Function indicator light(s), failure of 1
Image display error 1
Insulation degradation 1
Pacer found in back-up mode 1
Failure to run on portable mode 1
Device remains activated 1
Inappropriate shock 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 3688

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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