• 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
0 0 0 0 0 0 1 1 2 0

Device Problems
Electrical issue 459
Device displays error message 321
Failure to interrogate 209
Mechanical issue 201
No code available 197
Communication or transmission issue 159
Computer software issue 131
Computer operating system issue 95
Difficult to Program or Calibrate 90
No display or display failure 83
Device operates differently than expected 81
No Known Device Problem 62
Failure to power-up 59
Connection issue 52
No Information 49
Power source issue 42
Break 41
Difficult to interrogate 35
Inadequate user interface 33
Output issue 32
Artifact 32
High impedance 31
Material integrity issue 24
Component missing 21
Device inoperable 20
Overheating of device or device component 19
Incorrect display 19
Loose or intermittent connection 18
Failure to capture 18
Application interface becomes non-functional or program exits abnormally 16
Degraded 15
Oversensing 15
Inappropriate shock 14
Failure to calibrate 14
Data Issue 14
Noise, Audible 13
Ambient noise issue 13
Impedance issue 12
Defective item 11
Low impedance 10
Failure to pace or properly pace 10
Telemetry discrepancy 9
Device sensing issue 9
Operating system becomes non-functional 8
Improper or incorrect procedure or method 8
Loss of power 8
Crack 8
Implant, reprogramming of 7
Problem with software installation 6
Premature discharge of battery 6
No device output 5
Failure to transmit record 5
Unknown (for use when the device problem is not known) 5
Capturing issue 5
Issue with displayed error message 5
Device or device component damaged by another device 4
Programming issue 4
Device stops intermittently 4
Failure to shock or properly shock 4
Bent 4
Not audible alarm 4
Device alarm system issue 3
Burn of device or device component 3
Detachment of device component 3
Corrosion 3
Erratic display 3
Electro-magnetic interference (EMI) 3
Device emits odor 3
Unable to obtain readings 3
Noise 3
Incorrect software programming calculations 3
Not Applicable 3
Wireless communication issue 2
Device Contamination with biological material 2
Foreign material present in device 2
Failure to disconnect 2
Radio signal problem 2
Device remains activated 2
Undersensing 2
Use of Device Issue 2
Failure to sense 2
Migration of device or device component 2
Incorrect measurement 2
Kinked 2
Material frayed 2
Difficult to insert 1
Interference 1
Moisture damage 1
Dislodged 1
Display misread 1
Failure to run on AC/DC 1
Alarm, error of warning 1
Material separation 1
Loss of threshold 1
Smoking 1
Other (for use when an appropriate device code cannot be identified) 1
Device remains implanted 1
Incorrect or inadequate result 1
Product quality issue 1
Failure to prime 1
Total Device Problems 2982

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

-
-