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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
19 24 22 27 29 19 44 54 58 25

Device Problems
No Known Device Problem 105
Dislodged or dislocated 93
Failure to capture 89
No code available 83
Failure to pace or properly pace 81
Oversensing 69
High impedance 69
No Information 53
Device operates differently than expected 46
Normal 35
Premature discharge of battery 30
Low battery 30
Ambient noise issue 30
Pacer found in back-up mode 29
Connection issue 27
High sensing threshold 24
Use of Device Issue 22
Noise 22
Device sensing issue 21
Communication or transmission issue 20
Dislodged 19
Device displays error message 17
Unknown (for use when the device problem is not known) 15
Capturing issue 14
Malfunction 13
Premature elective replacement indicator 13
Explanted 13
Difficult to interrogate 13
Pocket stimulation 11
Failure to interrogate 10
Fracture 10
Mechanical issue 9
Telemetry discrepancy 9
Low impedance 9
Loss of threshold 8
Device remains implanted 8
Pacing inadequately 8
Electrical issue 8
Intermittent capture 7
High capture threshold 7
Output issue 7
Performance 6
Undersensing 6
Device damaged prior to use 6
Failure to sense 5
Not Applicable 5
Material integrity issue 5
Impedance issue 5
Sensing intermittently 4
Connection error 4
Migration of device or device component 4
Loose or intermittent connection 4
No device output 3
Contamination during use 3
False reading from device non-compliance 3
Electro-magnetic interference (EMI) 3
Malposition of device 3
Reset issue 3
Protective measure issue 2
Battery issue 2
Size incorrect for patient 2
Difficult to remove 2
Fitting problem 2
Device expiration issue 2
Break 2
Artifact 2
Incorrect measurement 2
Lead(s), fracture of 1
Pacing intermittently 1
Alarm, error of warning 1
Application interface becomes non-functional or program exits abnormally 1
Electrode(s), fracture of 1
Material separation 1
Inappropriate shock 1
Premature end-of-life indicator 1
Difficult to Program or Calibrate 1
Decreased sensitivity 1
Component missing 1
Out-of-box failure 1
Implant, repositioning of 1
Failure to deliver 1
Disinfection or Sterilization Issue at User Location 1
Device Contamination with biological material 1
Programming issue 1
No pacing 1
Inappropriate or unexpected reset 1
Device-device incompatibility 1
Human-Device Interface Issue 1
Total Device Problems 1317

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 0 0 1 0 1 0
Class III 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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