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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 8

Device Problems
No Known Device Problem 170
Failure to capture 96
Failure to pace or properly pace 94
Dislodged or dislocated 91
High impedance 88
Oversensing 86
No code available 83
No Information 54
Device operates differently than expected 51
Ambient noise issue 47
Normal 35
Use of Device Issue 32
Low battery 30
Premature discharge of battery 30
Pacer found in back-up mode 29
Connection issue 27
High sensing threshold 24
Device sensing issue 23
Capturing issue 22
Noise 22
Communication or transmission issue 20
Dislodged 19
Device displays error message 18
Unknown (for use when the device problem is not known) 15
Pocket stimulation 15
Premature elective replacement indicator 15
Malfunction 13
Explanted 13
Difficult to interrogate 13
Mechanical issue 12
Low impedance 12
Failure to interrogate 10
Fracture 9
Electrical issue 9
Telemetry discrepancy 9
Impedance issue 9
Loss of threshold 8
Undersensing 8
Device remains implanted 8
Pacing inadequately 8
Intermittent capture 7
Output issue 7
High capture threshold 7
Performance 6
Device damaged prior to use 6
Failure to sense 5
Material integrity issue 5
Not Applicable 5
Sensing intermittently 4
Connection error 4
Migration of device or device component 4
Loose or intermittent connection 4
Incorrect measurement 3
No device output 3
Contamination during use 3
False reading from device non-compliance 3
Electro-magnetic interference (EMI) 3
Malposition of device 3
Battery issue 3
Reset issue 3
Protective measure issue 2
Size incorrect for patient 2
Difficult to remove 2
Fitting problem 2
Device expiration issue 2
Break 2
Artifact 2
Alarm, error of warning 1
Application interface becomes non-functional or program exits abnormally 1
Electrode(s), fracture of 1
Pacing intermittently 1
Lead(s), fracture of 1
Material separation 1
Failure to shock or properly shock 1
Inappropriate shock 1
Difficult to Program or Calibrate 1
Unable to obtain readings 1
Premature end-of-life indicator 1
Disinfection or Sterilization Issue at User Location 1
Decreased sensitivity 1
Failure to disconnect 1
Component missing 1
Out-of-box failure 1
Implant, repositioning of 1
Failure to deliver 1
Programming issue 1
Inappropriate or unexpected reset 1
Low battery impedance 1
Human-Device Interface Issue 1
Device-device incompatibility 1
Device Contamination with biological material 1
No pacing 1
Total Device Problems 1504

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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