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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 0

Device Problems
No Known Device Problem 136
Failure to capture 96
Dislodged or dislocated 93
Failure to pace or properly pace 89
No code available 83
Oversensing 80
High impedance 79
No Information 54
Device operates differently than expected 47
Ambient noise issue 38
Normal 36
Premature discharge of battery 31
Low battery 30
Pacer found in back-up mode 29
Use of Device Issue 27
Connection issue 27
High sensing threshold 24
Device sensing issue 24
Noise 22
Capturing issue 20
Communication or transmission issue 20
Dislodged 19
Device displays error message 18
Unknown (for use when the device problem is not known) 15
Premature elective replacement indicator 15
Pocket stimulation 14
Malfunction 13
Explanted 13
Difficult to interrogate 13
Mechanical issue 12
Low impedance 12
Fracture 11
Failure to interrogate 10
Electrical issue 9
Telemetry discrepancy 9
Loss of threshold 8
Undersensing 8
Device remains implanted 8
Pacing inadequately 8
Impedance issue 8
High capture threshold 8
Output issue 7
Intermittent capture 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
Premature end-of-life indicator 1
Difficult to Program or Calibrate 1
Unable to obtain readings 1
Material perforation 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
Programming issue 1
Inappropriate or unexpected reset 1
Device Contamination with biological material 1
Device-device incompatibility 1
Human-Device Interface Issue 1
No pacing 1
Total Device Problems 1436

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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