• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 490
Device displays error message 329
Difficult to Program or Calibrate 294
Mechanical issue 233
Failure to interrogate 225
No display or display failure 200
No code available 197
Communication or transmission issue 188
Computer software issue 188
Computer operating system issue 169
Device operates differently than expected 153
Power source issue 116
Inadequate user interface 102
Connection issue 89
No Known Device Problem 88
Failure to power-up 88
Output issue 81
Failure to calibrate 72
Break 59
Artifact 57
High impedance 54
Overheating of device or device component 53
No Information 50
Material integrity issue 44
Difficult to interrogate 35
Noise, Audible 34
Application interface becomes non-functional or program exits abnormally 31
Oversensing 29
Problem with software installation 28
Ambient noise issue 27
Device sensing issue 27
Data Issue 26
Loose or intermittent connection 25
Corrosion 23
Failure to capture 23
Inappropriate shock 23
Crack 22
Component missing 22
Incorrect display 20
Device inoperable 20
Contamination during use 19
Degraded 19
Operating system becomes non-functional 18
Impedance issue 17
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
Device emits odor 9
Issue with displayed error message 9
Battery issue 8
No device output 8
Loss of power 8
Failure to sense 8
Failure to shock or properly shock 8
Improper or incorrect procedure or method 8
Failure to transmit record 7
Implant, reprogramming of 7
Bent 6
Not audible alarm 5
Unknown (for use when the device problem is not known) 5
Device stops intermittently 5
Calibration issue 5
Device or device component damaged by another device 4
Programming issue 4
Protective measure issue 4
Undersensing 4
Use of Device Issue 4
Noise 4
Erratic display 4
Electro-magnetic interference (EMI) 3
Moisture damage 3
Detachment of device component 3
Burn of device or device component 3
Incorrect software programming calculations 3
Unable to obtain readings 3
Not Applicable 3
Malfunction 3
Failure to disconnect 2
Blocked connection 2
Spark 2
Incorrect or inadequate test results 2
Foreign material present in device 2
Device Contamination with biological material 2
Wireless communication issue 2
Device remains activated 2
Product quality issue 2
Radio signal problem 2
Incorrect or inadequate result 2
Alarm, error of warning 2
Migration of device or device component 2
Incorrect measurement 2
Kinked 2
Difficult to insert 2
Material frayed 2
Interference 1
Failure to run on AC/DC 1
Total Device Problems 4383

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

-
-