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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 5
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 936
Loss of power 289
Mechanical issue 280
Failure to pace or properly pace 225
No display or display failure 188
Failure to power-up 160
Not Applicable 104
Device displays error message 99
Output issue 78
Device sensing issue 74
Electrical issue 69
Crack 59
Break 57
Defective item 50
No Information 48
Incorrect display 47
Power source issue 41
Failure to capture 40
No device output 36
Device inoperable 30
Failure to sense 26
Component missing 25
Other (for use when an appropriate device code cannot be identified) 24
No Known Device Problem 24
Use of Incorrect Control Settings 18
No pacing 17
Defective component 17
Failure of device to self-test 17
Output energy incorrect 15
Connection issue 15
Computer software issue 15
Failure to shut off 15
Corrosion 11
Oversensing 10
Undersensing 10
Low battery 9
Repair 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 4
Pacing asynchronously 4
Output above specifications 4
Output below specifications 4
Malfunction 3
Intermittent capture 3
Self-activation or keying 3
Battery failure 3
Failure to fire 3
Out-of-box failure 3
Detachment of device or device component 3
Incorrect measurement 3
Inaccurate delivery 2
Failure to calibrate 2
Overheating of device or device component 2
Use of Device Issue 2
Failure to run on AC/DC 2
Blocked connection 2
Calibration issue 2
Incorrect software programming calculations 2
Programming issue 2
Program, failure to 2
Sensing intermittently 2
Device contamination with blood or blood product 2
Disconnection 2
Loose or intermittent connection 2
Inadequate service 2
Device damaged prior to use 2
Difficult to Program or Calibrate 2
Misfire 2
Moisture or humidity problem 2
Decreased sensitivity 1
Device disinfection or sterilization issue 1
Electrical power problem 1
Inappropriate or unexpected reset 1
Scratched material 1
Device remains activated 1
Failure to run on portable mode 1
Moisture damage 1
Calibration error 1
High sensing threshold 1
Inappropriate shock 1
Blank screen 1
Pacer found in back-up mode 1
Application interface becomes non-functional or program exits abnormally 1
Material discolored 1
Function indicator light(s), failure of 1
Image display error 1
Battery issue 1
Improper alarm 1
Material integrity issue 1
Protective measure issue 1
Fracture 1
Alarm, failure of warning 1
Bent 1
Cable break 1
Incomplete or missing packaging 1
Total Device Problems 3327

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

Recalls
Manufacturer Recall Class Date Posted
1 Osypka Medical Inc II Sep-21-2010

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