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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 2017
0 0 0 0 0 0 0 0 0 12 0

Device Problems
Capturing issue 32
High capture threshold 25
Positioning Issue 14
Failure to capture 11
No Known Device Problem 10
Undersensing 5
Impedance issue 4
Use of Device Issue 4
Decreased sensitivity 3
Device sensing issue 3
Failure to pace or properly pace 3
Unstable capture threshold 3
Intermittent capture 2
Device operates differently than expected 2
Premature discharge of battery 2
No code available 2
Dislodged or dislocated 1
Incorrect measurement 1
Failure to interrogate 1
Electrical issue 1
High impedance 1
Migration of device or device component 1
Communication or transmission issue 1
Oversensing 1
Battery issue 1
Unable to obtain readings 1
Output issue 1
Leak 1
Protective measure issue 1
Total Device Problems 138

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