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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device programmer, pacemaker
Regulation Description Pacemaker programmers.
Product CodeKRG
Regulation Number 870.3700
Device Class 3


Premarket Reviews
ManufacturerDecision
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 3
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 7
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 1 1 2 0

Device Problems
Electrical issue 468
Device displays error message 324
Failure to interrogate 211
Mechanical issue 202
No code available 197
Communication or transmission issue 166
Computer software issue 151
Difficult to Program or Calibrate 143
Computer operating system issue 118
No display or display failure 110
Device operates differently than expected 98
No Known Device Problem 75
Failure to power-up 70
Connection issue 62
Power source issue 60
No Information 49
Inadequate user interface 49
Break 46
Output issue 45
High impedance 38
Difficult to interrogate 35
Artifact 35
Material integrity issue 32
Failure to calibrate 31
Overheating of device or device component 31
Oversensing 22
Component missing 21
Ambient noise issue 20
Noise, Audible 20
Device inoperable 20
Loose or intermittent connection 20
Incorrect display 19
Failure to capture 19
Application interface becomes non-functional or program exits abnormally 19
Inappropriate shock 18
Data Issue 17
Degraded 15
Failure to pace or properly pace 12
Low impedance 12
Impedance issue 12
Device sensing issue 12
Defective item 11
Problem with software installation 10
Telemetry discrepancy 10
Premature discharge of battery 9
Crack 9
Operating system becomes non-functional 9
Capturing issue 8
Improper or incorrect procedure or method 8
Loss of power 8
Corrosion 7
Implant, reprogramming of 7
Failure to transmit record 6
Device emits odor 5
No device output 5
Bent 5
Not audible alarm 5
Contamination during use 5
Unknown (for use when the device problem is not known) 5
Issue with displayed error message 5
Device or device component damaged by another device 4
Programming issue 4
Device alarm system issue 4
Device stops intermittently 4
Failure to shock or properly shock 4
Unable to obtain readings 3
Undersensing 3
Noise 3
Use of Device Issue 3
Moisture damage 3
Incorrect software programming calculations 3
Burn of device or device component 3
Detachment of device component 3
Electro-magnetic interference (EMI) 3
Erratic display 3
Not Applicable 3
Calibration issue 3
Spark 2
Failure to disconnect 2
Foreign material present in device 2
Device Contamination with biological material 2
Wireless communication issue 2
Kinked 2
Incorrect measurement 2
Migration of device or device component 2
Material frayed 2
Device remains activated 2
Product quality issue 2
Radio signal problem 2
Failure to sense 2
Material separation 1
Smoking 1
Other (for use when an appropriate device code cannot be identified) 1
Loss of threshold 1
Device remains implanted 1
Incorrect or inadequate result 1
Failure to prime 1
Output energy incorrect 1
Pacer found in back-up mode 1
Difficult to insert 1
Total Device Problems 3353

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 2 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific CRM Corp II Oct-07-2010
2 Boston Scientific CRM Corp II May-08-2010

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