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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 451
Device displays error message 321
Failure to interrogate 207
No code available 197
Mechanical issue 195
Communication or transmission issue 153
Computer software issue 123
Computer operating system issue 84
Device operates differently than expected 74
No display or display failure 66
No Known Device Problem 62
Difficult to Program or Calibrate 61
Failure to power-up 52
No Information 49
Connection issue 46
Break 38
Difficult to interrogate 35
High impedance 31
Power source issue 29
Artifact 28
Output issue 26
Material integrity issue 22
Device inoperable 20
Component missing 20
Inadequate user interface 19
Failure to capture 18
Incorrect display 18
Loose or intermittent connection 17
Application interface becomes non-functional or program exits abnormally 15
Degraded 15
Overheating of device or device component 15
Oversensing 14
Inappropriate shock 14
Ambient noise issue 13
Noise, Audible 12
Defective item 11
Impedance issue 10
Data Issue 10
Low impedance 10
Failure to pace or properly pace 10
Telemetry discrepancy 9
Failure to calibrate 9
Device sensing issue 8
Improper or incorrect procedure or method 8
Loss of power 8
Implant, reprogramming of 7
Operating system becomes non-functional 7
Premature discharge of battery 6
Crack 6
Unknown (for use when the device problem is not known) 5
Failure to transmit record 5
No device output 4
Device stops intermittently 4
Failure to shock or properly shock 4
Bent 4
Not audible alarm 4
Issue with displayed error message 4
Device or device component damaged by another device 4
Programming issue 4
Problem with software installation 3
Not Applicable 3
Capturing issue 3
Device alarm system issue 3
Burn of device or device component 3
Detachment of device component 3
Erratic display 3
Electro-magnetic interference (EMI) 3
Unable to obtain readings 3
Noise 3
Incorrect software programming calculations 3
Radio signal problem 2
Device remains activated 2
Use of Device Issue 2
Undersensing 2
Material frayed 2
Incorrect measurement 2
Kinked 2
Device emits odor 2
Migration of device or device component 2
Corrosion 2
Failure to disconnect 2
Device Contamination with biological material 2
Wireless communication issue 2
Protective measure issue 1
Reset issue 1
Dislodged or dislocated 1
Failure to shut off 1
Human-Device Interface Issue 1
Improper device output 1
Operating system version or upgrade problem 1
Mechanical jam 1
Low battery 1
Spark 1
Cut in material 1
Incorrect or inadequate test results 1
Low readings 1
Charging issue 1
Calibration issue 1
Data back-up problem 1
Delamination 1
Total Device Problems 2797

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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