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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 14

Device Problems
Capturing issue 75
High capture threshold 50
No Known Device Problem 48
Failure to capture 32
Positioning Issue 21
Undersensing 15
Use of Device Issue 14
Failure to pace or properly pace 12
Dislodged or dislocated 12
Impedance issue 11
No code available 10
Device operates differently than expected 7
Device sensing issue 6
Premature discharge of battery 6
Decreased sensitivity 5
Unstable capture threshold 5
Oversensing 4
Communication or transmission issue 3
Inappropriate or unexpected reset 3
Battery issue 3
Unable to obtain readings 3
Intermittent capture 3
High impedance 2
Electrical issue 2
Leak 2
Incorrect measurement 2
Migration of device or device component 2
Output issue 2
Protective measure issue 1
Reset issue 1
Data Issue 1
Device handling issue 1
Material integrity issue 1
Difficult to remove 1
Difficult to flush 1
Fracture 1
Failure to interrogate 1
Kinked 1
Total Device Problems 370

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