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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 2017
0 0 0 0 0 0 1 1 2 0 0

Device Problems
Electrical issue 484
Device displays error message 329
Difficult to Program or Calibrate 252
Mechanical issue 227
Failure to interrogate 218
No code available 197
Communication or transmission issue 181
Computer software issue 181
No display or display failure 163
Computer operating system issue 154
Device operates differently than expected 145
Power source issue 97
No Known Device Problem 88
Connection issue 85
Failure to power-up 81
Inadequate user interface 79
Output issue 73
Failure to calibrate 62
Break 55
High impedance 54
Artifact 50
No Information 50
Overheating of device or device component 48
Material integrity issue 38
Difficult to interrogate 35
Noise, Audible 32
Application interface becomes non-functional or program exits abnormally 29
Oversensing 28
Ambient noise issue 27
Device sensing issue 25
Problem with software installation 24
Data Issue 23
Inappropriate shock 23
Loose or intermittent connection 23
Failure to capture 22
Component missing 22
Incorrect display 20
Device inoperable 20
Corrosion 19
Crack 18
Degraded 18
Impedance issue 17
Operating system becomes non-functional 15
Contamination during use 15
Failure to pace or properly pace 14
Low impedance 13
Premature discharge of battery 13
Capturing issue 11
Defective item 11
Device alarm system issue 10
Telemetry discrepancy 10
Issue with displayed error message 9
Failure to shock or properly shock 8
Improper or incorrect procedure or method 8
No device output 8
Loss of power 8
Failure to transmit record 7
Implant, reprogramming of 7
Battery issue 6
Device emits odor 6
Unknown (for use when the device problem is not known) 5
Device stops intermittently 5
Failure to sense 5
Not audible alarm 5
Bent 5
Undersensing 4
Use of Device Issue 4
Noise 4
Device or device component damaged by another device 4
Calibration issue 4
Programming issue 4
Protective measure issue 4
Not Applicable 3
Malfunction 3
Incorrect software programming calculations 3
Unable to obtain readings 3
Detachment of device component 3
Burn of device or device component 3
Electro-magnetic interference (EMI) 3
Erratic display 3
Moisture damage 3
Migration of device or device component 2
Incorrect measurement 2
Kinked 2
Difficult to insert 2
Material frayed 2
Alarm, error of warning 2
Device remains activated 2
Product quality issue 2
Radio signal problem 2
Incorrect or inadequate result 2
Incorrect or inadequate test results 2
Failure to disconnect 2
Blocked connection 2
Low battery 2
Spark 2
Device Contamination with biological material 2
Foreign material present in device 2
Wireless communication issue 2
Reset issue 1
Total Device Problems 4112

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 2 0 0 0 0 0 1 0
Class III 0 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
3 Sorin Group USA, Inc. II Nov-15-2016

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