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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 18

Device Problems
Dislodged or dislocated 93
Failure to capture 85
No code available 83
No Known Device Problem 82
Failure to pace or properly pace 76
Oversensing 64
High impedance 60
No Information 53
Device operates differently than expected 40
Normal 35
Low battery 30
Premature discharge of battery 29
Pacer found in back-up mode 28
Connection issue 25
Ambient noise issue 24
High sensing threshold 24
Noise 22
Device sensing issue 20
Dislodged 19
Communication or transmission issue 18
Device displays error message 17
Unknown (for use when the device problem is not known) 15
Use of Device Issue 15
Malfunction 13
Capturing issue 13
Explanted 13
Difficult to interrogate 13
Premature elective replacement indicator 12
Failure to interrogate 10
Fracture 10
Mechanical issue 9
Pocket stimulation 9
Telemetry discrepancy 9
Loss of threshold 8
Device remains implanted 8
Low impedance 8
Pacing inadequately 8
Intermittent capture 7
Output issue 7
High capture threshold 7
Electrical issue 6
Device damaged prior to use 6
Performance 6
Undersensing 5
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
Electro-magnetic interference (EMI) 3
False reading from device non-compliance 3
Malposition of device 3
Reset issue 3
Protective measure issue 2
Battery issue 2
Difficult to remove 2
Size incorrect for patient 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
Fitting problem 1
Material separation 1
Inappropriate shock 1
Premature end-of-life indicator 1
Difficult to Program or Calibrate 1
Disinfection or Sterilization Issue at User Location 1
Decreased sensitivity 1
Component missing 1
Out-of-box failure 1
Implant, repositioning of 1
Failure to deliver 1
Programming issue 1
No pacing 1
Inappropriate or unexpected reset 1
Human-Device Interface Issue 1
Device-device incompatibility 1
Device Contamination with biological material 1
Total Device Problems 1236

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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