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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
Connection issue 391
Mechanical issue 371
Loss of power 289
No display or display failure 226
Failure to pace or properly pace 218
Device displays error message 197
Failure to power-up 180
Output issue 114
Not Applicable 104
Device sensing issue 95
Electrical issue 92
Break 91
Crack 66
Power source issue 63
No device output 61
Component missing 52
Defective item 51
No Information 49
Incorrect display 47
Failure to capture 44
Failure to sense 38
Calibration issue 35
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
Undersensing 23
Device operates differently than expected 22
No pacing 20
Failure of device to self-test 19
Failure to shut off 18
Computer software issue 18
Use of Incorrect Control Settings 18
Defective component 17
Corrosion 16
Output energy incorrect 15
Contamination during use 14
Material integrity issue 14
Oversensing 13
Loose or intermittent connection 12
Low battery 11
Pacing intermittently 8
Repair 8
Device stops intermittently 7
Improper device output 7
Degraded 6
Premature discharge of battery 6
Moisture damage 5
Sensitivity 5
Pacing inadequately 5
Difficult to Program or Calibrate 5
Output below specifications 5
Battery issue 4
Pacing asynchronously 4
Output above specifications 4
Intermittent capture 4
Battery failure 3
Incorrect measurement 3
Self-activation or keying 3
Out-of-box failure 3
Blocked connection 3
Failure to fire 3
Detachment of device or device component 3
Malfunction 3
Foreign material present in device 3
Dislodged or dislocated 2
Inadequate user interface 2
Impedance issue 2
Failure to calibrate 2
Misfire 2
Device contamination with blood or blood product 2
Inaccurate delivery 2
Moisture or humidity problem 2
Operating system becomes non-functional 2
Programming issue 2
Noise, Audible 2
Device damaged prior to use 2
Use of Device Issue 2
Sensing intermittently 2
Inadequate service 2
Overheating of device or device component 2
Disconnection 2
Program, failure to 2
Incorrect software programming calculations 2
Difficult to insert 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
Detachment of device component 1
Insulation degradation 1
Material discolored 1
Application interface becomes non-functional or program exits abnormally 1
Fracture 1
Total Device Problems 4328

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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