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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
BIOTRONIK GMBG & CO.
  3
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 3
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 6
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 14
MEDTRONIC, INC.
  2
  SUBSTANTIALLY EQUIVALENT 19
OSCOR, INC.
  1
  SUBSTANTIALLY EQUIVALENT 3
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
TELECTRONICS
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No code available 16
High impedance 12
No Known Device Problem 5
No Information 4
Failure to capture 4
Fracture 4
Fitting problem 4
Unknown (for use when the device problem is not known) 3
Low impedance 3
Oversensing 3
Defective item 3
Impedance issue 2
Material integrity issue 2
Capturing issue 2
Connection issue 2
Device sensing issue 2
Failure to disconnect 2
Break 2
Device remains activated 2
Failure to sense 1
Sensitivity 1
Inappropriate shock 1
Use of Device Issue 1
Insulation, hole(s) in 1
Mechanical issue 1
Misapplication 1
Normal 1
Adaptor, failure of 1
Artifact 1
Component(s), broken 1
Elective replacement 1
Device expiration issue 1
High sensing threshold 1
Performance 1
User used incorrect product for intended use 1
Structural problem 1
Dislodged or dislocated 1
Device displays error message 1
Output issue 1
High capture threshold 1
Total Device Problems 98

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