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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pacemaker lead adaptor
Regulation Description Pacemaker lead adaptor.
Product CodeDTD
Regulation Number 870.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 48
High impedance 10
Over-Sensing 8
Signal Artifact 7
High Capture Threshold 7
Fracture 6
Impedance Problem 6
Connection Problem 5
Low impedance 4
Ambient Noise Problem 4
Insufficient Information 3
Failure to Capture 3
Electrical /Electronic Property Problem 2
Mechanical Problem 2
Material Integrity Problem 2
Capturing Problem 2
Device Dislodged or Dislocated 1
Pocket Stimulation 1
Material Deformation 1
Pacing Problem 1
Device Operates Differently Than Expected 1
Electronic Property Issue 1
Device Markings / Labelling Problem 1
Difficult or Delayed Positioning 1
Human-Device Interface Problem 1
Appropriate Term/Code Not Available 1
High Sensing Threshold 1
Intermittent Capture 1
Unstable Capture Threshold 1
Total Device Problems 132


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