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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 10

Device Problems
Dislodged or dislocated 93
Failure to capture 85
No code available 83
No Known Device Problem 81
Failure to pace or properly pace 76
Oversensing 63
High impedance 60
No Information 53
Device operates differently than expected 39
Normal 35
Low battery 30
Premature discharge of battery 29
Pacer found in back-up mode 28
Connection issue 25
High sensing threshold 24
Ambient noise issue 23
Noise 22
Device sensing issue 20
Dislodged 19
Communication or transmission issue 18
Device displays error message 17
Use of Device Issue 15
Unknown (for use when the device problem is not known) 15
Explanted 13
Capturing issue 13
Difficult to interrogate 13
Malfunction 13
Premature elective replacement indicator 12
Fracture 10
Failure to interrogate 10
Pocket stimulation 9
Telemetry discrepancy 9
Mechanical issue 9
Device remains implanted 8
Loss of threshold 8
Low impedance 8
Pacing inadequately 8
High capture threshold 7
Output issue 7
Intermittent capture 7
Device damaged prior to use 6
Performance 6
Electrical issue 6
Not Applicable 5
Material integrity issue 5
Failure to sense 5
Impedance issue 5
Undersensing 5
Sensing intermittently 4
Loose or intermittent connection 4
Connection error 4
Migration of device or device component 4
False reading from device non-compliance 3
Contamination during use 3
No device output 3
Malposition of device 3
Reset issue 3
Electro-magnetic interference (EMI) 3
Protective measure issue 2
Size incorrect for patient 2
Device expiration issue 2
Break 2
Battery issue 2
Difficult to remove 2
Artifact 2
Incorrect measurement 2
Electrode(s), fracture of 1
Component missing 1
Implant, repositioning of 1
Failure to deliver 1
Disinfection or Sterilization Issue at User Location 1
Difficult to Program or Calibrate 1
Decreased sensitivity 1
Inappropriate or unexpected reset 1
No pacing 1
Alarm, error of warning 1
Programming issue 1
Application interface becomes non-functional or program exits abnormally 1
Inappropriate shock 1
Lead(s), fracture of 1
Premature end-of-life indicator 1
Fitting problem 1
Device Contamination with biological material 1
Device-device incompatibility 1
Out-of-box failure 1
Pacing intermittently 1
Material separation 1
Total Device Problems 1231

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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