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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device recorder,event,implantable cardiac,(without arrhythmia detection)
Regulation Description Medical magnetic tape recorder.
Product CodeMXC
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  1
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Pacer found in back-up mode 124
Device displays error message 89
Undersensing 63
Failure to interrogate 45
Oversensing 33
Device operates differently than expected 25
Premature discharge of battery 16
Premature elective replacement indicator 13
Failure to sense 10
No Known Device Problem 9
Device sensing issue 8
Electro-magnetic interference (EMI) 6
Difficult to interrogate 5
Low battery 4
Sensing intermittently 3
Telemetry discrepancy 3
Failure to transmit record 3
Device remains activated 2
Failure to capture 2
No device output 2
No code available 2
Inappropriate or unexpected reset 2
Other (for use when an appropriate device code cannot be identified) 2
Invalid sensing 1
Decreased sensitivity 1
Year 2000 (Y2K) related problem 1
Defective item 1
Improper or incorrect procedure or method 1
Loss of Data 1
Detachment of device or device component 1
Power source issue 1
Overheating of device or device component 1
Migration of device or device component 1
Incorrect display 1
Image display error 1
Premature end-of-life indicator 1
Total Device Problems 484

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 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 St Jude Medical CRMD II Jul-05-2011

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