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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device leadless pacemaker
Regulation Description Implantable pacemaker pulse generator.
Definition To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Product CodePNJ
Regulation Number 870.3610
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 0 0 0 7

Device Problems
Capturing issue 14
High capture threshold 9
Positioning Issue 6
No Known Device Problem 4
Undersensing 4
Failure to capture 4
Use of Device Issue 3
Impedance issue 3
Intermittent capture 2
Unstable capture threshold 2
No code available 1
Output issue 1
Battery issue 1
Device operates differently than expected 1
Device sensing issue 1
Leak 1
Incorrect measurement 1
Failure to pace or properly pace 1
Unable to obtain readings 1
Total Device Problems 60

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