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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
12 31 20 28 16 19 24 20 18 20

Device Problems
Oversensing 485
Inappropriate shock 283
Failure to interrogate 135
Explanted 133
Normal 127
No Information 122
Premature elective replacement indicator 115
High impedance 107
Device remains implanted 98
No Known Device Problem 95
Low impedance 90
Device operates differently than expected 88
Pacer found in back-up mode 88
Premature end-of-life indicator 88
Device displays error message 83
Connection issue 72
Failure to deploy 61
Failure to shock or properly shock 54
Ambient noise issue 53
Premature discharge of battery 52
Incorrect display 51
Unable to obtain readings 44
Undersensing 38
No code available 33
Other (for use when an appropriate device code cannot be identified) 31
Electrode(s), failure of 31
Difficult to interrogate 30
Incorrect interpretation of rhythm 30
Impedance issue 29
Failure to transmit record 27
Failure to capture 26
Failure to pace or properly pace 24
Communication or transmission issue 19
High sensing threshold 18
Incorrect or inadequate result 18
Mechanical issue 18
Application interface becomes non-functional or program exits abnormally 17
Failure to deliver energy 17
Material deformation 16
No display or display failure 15
Computer software issue 15
Material perforation 15
Pacing inadequately 14
Difficult to Program or Calibrate 13
Dislodged or dislocated 13
Programming issue 13
Reset issue 12
Out-of-box failure 12
Artifact 12
Dislodged 12
Failure to charge 11
Loose or intermittent connection 11
Incorrect or inadequate test results 11
Telemetry discrepancy 11
Inadequate user interface 11
Device sensing issue 11
Charging issue 11
Failure to analyze rhythm 10
Failure to convert rhythm 10
Not Applicable 10
Low battery 9
Intermittent continuity 9
Display misread 9
Migration of device or device component 8
Difficult to advance 8
Failure to sense 8
Noise 7
Issue with displayed error message 7
Material puncture 7
Intermittent capture 7
Fracture 7
Bent 6
No device output 6
Loss of Data 6
Retraction problem 6
High capture threshold 6
Wireless communication issue 6
Deployment issue 5
Insulation degradation 5
Failure to deliver countershock 5
Degraded 5
Electro-magnetic interference (EMI) 5
Erratic display 4
Break 4
Performance 4
Operating system becomes non-functional 4
Malfunction 4
Battery issue 4
Sensing intermittently 4
Unexpected therapeutic results 3
Steering wire problem 3
Malposition of device 3
Delayed charge time 3
Inappropriate or unexpected reset 3
Difficult to position 3
Pacing intermittently 3
Device remains activated 3
Lead(s), breakage of 3
Elective removal 3
Material erosion 3
Total Device Problems 3407

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

Recalls
Manufacturer Recall Class Date Posted
1 Biotronik Inc III Jul-29-2008
2 Sorin Group USA, Inc. II Mar-08-2013
3 ela Medical Llc II Jun-22-2011

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