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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 13

Device Problems
Capturing issue 60
High capture threshold 41
No Known Device Problem 37
Failure to capture 22
Positioning Issue 17
Undersensing 11
Use of Device Issue 9
No code available 9
Impedance issue 8
Failure to pace or properly pace 8
Device operates differently than expected 7
Dislodged or dislocated 7
Device sensing issue 6
Unstable capture threshold 5
Decreased sensitivity 4
Battery issue 3
Premature discharge of battery 3
Oversensing 3
Inappropriate or unexpected reset 2
Output issue 2
Intermittent capture 2
Electrical issue 2
High impedance 2
Leak 2
Incorrect measurement 2
Migration of device or device component 2
Unable to obtain readings 2
Difficult to remove 1
Communication or transmission issue 1
Failure to interrogate 1
Kinked 1
Difficult to flush 1
Material integrity issue 1
Data Issue 1
Device handling issue 1
Protective measure issue 1
Total Device Problems 287

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