• 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 460
Device displays error message 324
Failure to interrogate 209
Mechanical issue 201
No code available 197
Communication or transmission issue 161
Computer software issue 132
Computer operating system issue 96
Difficult to Program or Calibrate 91
Device operates differently than expected 90
No display or display failure 84
No Known Device Problem 75
Failure to power-up 60
Connection issue 54
No Information 49
Power source issue 42
Break 41
High impedance 38
Difficult to interrogate 35
Inadequate user interface 33
Output issue 32
Artifact 32
Material integrity issue 28
Oversensing 22
Component missing 21
Device inoperable 20
Overheating of device or device component 20
Failure to capture 19
Application interface becomes non-functional or program exits abnormally 19
Incorrect display 19
Ambient noise issue 19
Loose or intermittent connection 18
Inappropriate shock 18
Degraded 15
Failure to calibrate 15
Data Issue 14
Noise, Audible 14
Impedance issue 12
Device sensing issue 12
Low impedance 12
Failure to pace or properly pace 12
Defective item 11
Telemetry discrepancy 9
Premature discharge of battery 9
Crack 8
Improper or incorrect procedure or method 8
Loss of power 8
Operating system becomes non-functional 8
Capturing issue 7
Implant, reprogramming of 7
Problem with software installation 6
Issue with displayed error message 5
Unknown (for use when the device problem is not known) 5
No device output 5
Failure to transmit record 5
Not audible alarm 5
Device alarm system issue 4
Bent 4
Device emits odor 4
Device stops intermittently 4
Failure to shock or properly shock 4
Device or device component damaged by another device 4
Programming issue 4
Not Applicable 3
Unable to obtain readings 3
Noise 3
Use of Device Issue 3
Incorrect software programming calculations 3
Erratic display 3
Electro-magnetic interference (EMI) 3
Burn of device or device component 3
Detachment of device component 3
Corrosion 3
Material frayed 2
Migration of device or device component 2
Incorrect measurement 2
Kinked 2
Device remains activated 2
Product quality issue 2
Radio signal problem 2
Failure to sense 2
Undersensing 2
Wireless communication issue 2
Device Contamination with biological material 2
Foreign material present in device 2
Failure to disconnect 2
Low battery 1
Spark 1
Cut in material 1
Incorrect or inadequate test results 1
Low readings 1
Battery issue 1
Blocked connection 1
Calibration issue 1
Data back-up problem 1
Delamination 1
Human-Device Interface Issue 1
Improper device output 1
Mechanical jam 1
Charging issue 1
Total Device Problems 3069

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

-
-