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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pacemaker/icd/crt non-implanted components
Definition Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Product CodeOSR
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 1 1 2 8 8 3

Device Problems
Device operates differently than expected 8
Failure to pace or properly pace 5
Ambient noise issue 4
Inappropriate shock 3
Oversensing 3
Inadequate user interface 3
Power source issue 2
Computer software issue 2
High impedance 2
Failure to interrogate 2
Undersensing 2
Device displays error message 2
Computer operating system issue 2
Device sensing issue 1
Low impedance 1
Capturing issue 1
Fire 1
Device alarm system issue 1
Failure to power-up 1
No Known Device Problem 1
Total Device Problems 47

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