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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Definition These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.
Product CodeNKE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
19 24 22 27 29 19 44 54 58 33 1

Device Problems
No Known Device Problem 136
Failure to capture 96
Dislodged or dislocated 93
Failure to pace or properly pace 89
No code available 83
Oversensing 80
High impedance 79
No Information 54
Device operates differently than expected 47
Ambient noise issue 38
Normal 36
Premature discharge of battery 31
Low battery 30
Pacer found in back-up mode 29
Connection issue 27
Use of Device Issue 27
Device sensing issue 24
High sensing threshold 24
Noise 22
Communication or transmission issue 20
Capturing issue 20
Dislodged 19
Device displays error message 18
Unknown (for use when the device problem is not known) 15
Premature elective replacement indicator 15
Pocket stimulation 14
Difficult to interrogate 13
Explanted 13
Malfunction 13
Mechanical issue 12
Low impedance 12
Fracture 11
Failure to interrogate 10
Electrical issue 9
Telemetry discrepancy 9
Undersensing 8
Device remains implanted 8
High capture threshold 8
Loss of threshold 8
Impedance issue 8
Pacing inadequately 8
Intermittent capture 7
Output issue 7
Device damaged prior to use 6
Performance 6
Material integrity issue 5
Failure to sense 5
Not Applicable 5
Migration of device or device component 4
Loose or intermittent connection 4
Connection error 4
Sensing intermittently 4
Reset issue 3
Electro-magnetic interference (EMI) 3
No device output 3
Malposition of device 3
False reading from device non-compliance 3
Contamination during use 3
Battery issue 3
Incorrect measurement 3
Artifact 2
Difficult to remove 2
Device expiration issue 2
Break 2
Protective measure issue 2
Fitting problem 2
Size incorrect for patient 2
Device-device incompatibility 1
Device Contamination with biological material 1
Pacing intermittently 1
Out-of-box failure 1
Material separation 1
Material perforation 1
Lead(s), fracture of 1
Failure to disconnect 1
Unable to obtain readings 1
Failure to shock or properly shock 1
Premature end-of-life indicator 1
Programming issue 1
Alarm, error of warning 1
Human-Device Interface Issue 1
Inappropriate shock 1
Application interface becomes non-functional or program exits abnormally 1
Component missing 1
Implant, repositioning of 1
Electrode(s), fracture of 1
Failure to deliver 1
Disinfection or Sterilization Issue at User Location 1
Decreased sensitivity 1
No pacing 1
Inappropriate or unexpected reset 1
Difficult to Program or Calibrate 1
Total Device Problems 1436

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 0 0 1 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Nov-27-2015
2 Medtronic Inc. Cardiac Rhythm Disease Management II Jun-27-2013

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