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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 3

Device Problems
Oversensing 513
Inappropriate shock 297
Failure to interrogate 152
Explanted 131
Normal 125
Premature elective replacement indicator 122
No Information 121
No Known Device Problem 113
High impedance 109
Device remains implanted 98
Device operates differently than expected 97
Pacer found in back-up mode 93
Premature end-of-life indicator 92
Device displays error message 92
Low impedance 92
Connection issue 74
Failure to deploy 61
Premature discharge of battery 60
Ambient noise issue 58
Failure to shock or properly shock 56
Incorrect display 56
Unable to obtain readings 44
Undersensing 39
Other (for use when an appropriate device code cannot be identified) 31
Impedance issue 31
Difficult to interrogate 31
Electrode(s), failure of 31
Incorrect interpretation of rhythm 30
No code available 30
Failure to transmit record 29
Failure to capture 27
Communication or transmission issue 26
Failure to pace or properly pace 24
Application interface becomes non-functional or program exits abnormally 21
Mechanical issue 18
High sensing threshold 18
Incorrect or inadequate result 18
Failure to deliver energy 17
Material deformation 16
Programming issue 15
Reset issue 15
No display or display failure 15
Computer software issue 15
Pacing inadequately 15
Material perforation 15
Dislodged or dislocated 13
Difficult to Program or Calibrate 13
Loose or intermittent connection 12
Artifact 12
Dislodged 12
Incorrect or inadequate test results 12
Out-of-box failure 12
Telemetry discrepancy 11
Inadequate user interface 11
Device sensing issue 11
Charging issue 11
Failure to charge 11
Low battery 10
Failure to analyze rhythm 10
Failure to convert rhythm 10
Not Applicable 10
Intermittent continuity 9
Display misread 9
Migration of device or device component 8
Failure to sense 8
Difficult to advance 8
Wireless communication issue 8
Issue with displayed error message 7
Noise 7
Material puncture 7
Intermittent capture 7
Fracture 7
Bent 6
No device output 6
Retraction problem 6
Loss of Data 6
Battery issue 6
High capture threshold 6
Deployment issue 5
Inappropriate or unexpected reset 5
Unexpected therapeutic results 5
Insulation degradation 5
Failure to deliver countershock 5
Degraded 5
Electro-magnetic interference (EMI) 5
Erratic display 4
Break 4
Performance 4
Malfunction 4
Sensing intermittently 4
Operating system becomes non-functional 4
Data Issue 3
No pacing 3
Steering wire problem 3
Delayed charge time 3
Malposition of device 3
Difficult to position 3
Pacing intermittently 3
Device remains activated 3
Lead(s), breakage of 3
Total Device Problems 3571

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 0
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 USA, Inc. II Mar-08-2013
3 ela Medical Llc II Jun-22-2011

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