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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.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Pacer found in back-up mode 9
No Known Device Problem 9
Failure to interrogate 8
Premature elective replacement indicator 7
Premature discharge of battery 5
Low battery 4
Failure to transmit record 3
Device remains activated 2
Other (for use when an appropriate device code cannot be identified) 2
Electro-magnetic interference (EMI) 2
Difficult to interrogate 2
No device output 2
No code available 2
Power source issue 1
Defective item 1
Detachment of device or device component 1
Device sensing issue 1
Overheating of device or device component 1
Migration of device or device component 1
Failure to capture 1
Incorrect display 1
Invalid sensing 1
Premature end-of-life indicator 1
Telemetry discrepancy 1
Total Device Problems 68

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0
Class III 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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