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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device defibrillator, implantable, dual-chamber
Product CodeMRM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
12 31 20 28 16 19 24 20 18 20 22

Device Problems
Oversensing 558
Inappropriate shock 323
Failure to interrogate 176
No Known Device Problem 168
Explanted 131
Premature elective replacement indicator 129
Normal 125
No Information 122
High impedance 120
Pacer found in back-up mode 111
Device operates differently than expected 109
Premature end-of-life indicator 107
Device displays error message 101
Device remains implanted 98
Low impedance 94
Connection issue 75
Premature discharge of battery 71
Ambient noise issue 65
Failure to deploy 61
Incorrect display 59
Failure to shock or properly shock 58
Unable to obtain readings 44
Undersensing 41
Application interface becomes non-functional or program exits abnormally 37
Communication or transmission issue 36
Difficult to interrogate 35
No code available 34
Impedance issue 33
Failure to capture 32
Electrode(s), failure of 31
Other (for use when an appropriate device code cannot be identified) 31
Incorrect interpretation of rhythm 30
Failure to transmit record 29
Failure to pace or properly pace 24
Mechanical issue 18
Incorrect or inadequate result 18
High sensing threshold 18
Failure to deliver energy 17
Reset issue 17
Programming issue 16
Material deformation 16
No display or display failure 16
Pacing inadequately 16
Computer software issue 15
Material perforation 15
Dislodged or dislocated 13
Difficult to Program or Calibrate 13
Loose or intermittent connection 12
Artifact 12
Dislodged 12
Device sensing issue 12
Charging issue 12
Incorrect or inadequate test results 12
Out-of-box failure 12
Telemetry discrepancy 11
Inadequate user interface 11
Inappropriate or unexpected reset 11
Failure to charge 11
Fracture 10
Low battery 10
Failure to analyze rhythm 10
Failure to convert rhythm 10
Not Applicable 10
Wireless communication issue 10
Failure to sense 9
Battery issue 9
Issue with displayed error message 9
Intermittent capture 9
Intermittent continuity 9
Display misread 9
Migration of device or device component 8
Difficult to advance 8
Loss of Data 7
Noise 7
Material puncture 7
No device output 6
Bent 6
Unexpected therapeutic results 6
Retraction problem 6
High capture threshold 6
No pacing 5
Operating system becomes non-functional 5
Deployment issue 5
Failure to deliver countershock 5
Degraded 5
Electro-magnetic interference (EMI) 5
Insulation degradation 5
Performance 4
Erratic display 4
Break 4
Delayed charge time 4
Sensing intermittently 4
Malfunction 4
Data Issue 4
Unstable capture threshold 3
Steering wire problem 3
Malposition of device 3
Elective removal 3
Material erosion 3
Foreign material 3
Total Device Problems 3896

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 1 0 0 0 2
Class III 0 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biotronik Inc III Jul-29-2008
2 Sorin Group Italia SRL - CRF II Sep-28-2017
3 Sorin Group Italia SRL - CRF II May-18-2017
4 Sorin Group USA, Inc. II Mar-08-2013
5 ela Medical Llc II Jun-22-2011

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