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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 19

Device Problems
No Known Device Problem 214
Oversensing 102
Failure to pace or properly pace 102
High impedance 101
Failure to capture 101
Dislodged or dislocated 91
No code available 83
Device operates differently than expected 58
Ambient noise issue 55
No Information 54
Premature discharge of battery 39
Pacer found in back-up mode 37
Use of Device Issue 36
Normal 35
Low battery 30
Connection issue 27
High sensing threshold 24
Device sensing issue 24
Capturing issue 24
Device displays error message 23
Noise 22
Communication or transmission issue 21
Dislodged 19
Pocket stimulation 16
Premature elective replacement indicator 15
Unknown (for use when the device problem is not known) 15
Low impedance 13
Malfunction 13
Explanted 13
Difficult to interrogate 13
Failure to interrogate 12
Mechanical issue 12
Telemetry discrepancy 10
Impedance issue 10
Undersensing 9
Fracture 9
Electrical issue 9
Pacing inadequately 8
Loss of threshold 8
Device remains implanted 8
Intermittent capture 7
Output issue 7
High capture threshold 7
Material integrity issue 6
Performance 6
Device damaged prior to use 6
Failure to sense 5
No device output 5
Incorrect measurement 5
Not Applicable 5
Loose or intermittent connection 4
Migration of device or device component 4
Connection error 4
Sensing intermittently 4
Malposition of device 3
Battery issue 3
Contamination during use 3
False reading from device non-compliance 3
Electro-magnetic interference (EMI) 3
Reset issue 3
Protective measure issue 2
Device expiration issue 2
Break 2
Artifact 2
Fitting problem 2
Difficult to remove 2
Size incorrect for patient 2
Material separation 1
Failure to shock or properly shock 1
Inappropriate shock 1
Incorrect or inadequate result 1
Difficult to Program or Calibrate 1
Unable to obtain readings 1
Premature end-of-life indicator 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
Decreased sensitivity 1
Failure to disconnect 1
Alarm, error of warning 1
Application interface becomes non-functional or program exits abnormally 1
Electrode(s), fracture of 1
Pacing intermittently 1
Material frayed 1
Lead(s), fracture of 1
Programming issue 1
Inappropriate or unexpected reset 1
Low battery impedance 1
Device Contamination with biological material 1
Device-device incompatibility 1
Human-Device Interface Issue 1
No pacing 1
Total Device Problems 1649

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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