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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 10

Device Problems
Oversensing 457
Inappropriate shock 271
Explanted 132
Normal 126
Failure to interrogate 124
No Information 112
Premature elective replacement indicator 104
High impedance 104
Device remains implanted 98
Low impedance 88
Device operates differently than expected 88
No Known Device Problem 83
Premature end-of-life indicator 80
Device displays error message 78
Pacer found in back-up mode 77
Connection issue 71
Failure to deploy 61
Failure to shock or properly shock 53
Incorrect display 46
Premature discharge of battery 45
Unable to obtain readings 44
Ambient noise issue 44
Undersensing 37
No code available 32
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 26
Failure to transmit record 26
Failure to pace or properly pace 23
Failure to capture 23
Mechanical issue 18
High sensing threshold 18
Incorrect or inadequate result 18
Communication or transmission issue 17
Application interface becomes non-functional or program exits abnormally 17
Failure to deliver energy 17
Material deformation 16
Computer software issue 15
Material perforation 15
No display or display failure 14
Pacing inadequately 14
Difficult to Program or Calibrate 13
Dislodged or dislocated 13
Programming issue 13
Out-of-box failure 12
Artifact 12
Dislodged 12
Failure to charge 11
Loose or intermittent connection 11
Incorrect or inadequate test results 11
Inadequate user interface 11
Charging issue 11
Device sensing issue 10
Failure to analyze rhythm 10
Failure to convert rhythm 10
Reset issue 9
Low battery 9
Intermittent continuity 9
Display misread 9
Not Applicable 9
Difficult to advance 8
Failure to sense 8
Telemetry discrepancy 8
Noise 7
Intermittent capture 7
Fracture 7
Migration of device or device component 7
Material puncture 7
No device output 6
Bent 6
Retraction problem 6
Issue with displayed error message 6
Loss of Data 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
Battery issue 4
Malfunction 4
High capture threshold 4
No pacing 3
Malposition of device 3
Delayed charge time 3
Steering wire problem 3
Elective removal 3
Foreign material 3
Difficult to position 3
Pacing intermittently 3
Device remains activated 3
Lead(s), breakage of 3
Incorrect measurement 2
Nonstandard device or device component 2
Output energy incorrect 2
Incorrect software programming calculations 2
Total Device Problems 3234

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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