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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
  1.  K132008  6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, ...
  2.  K772058  LEAD ADAPTOR KIT MODEL 5866-21
  3.  K811349  MODEL 5866-24 LEAD ADAPTOR KIT
  4.  K820935  MODEL 5866-26 LEAD ADAPTER KIT
  5.  K842065  EPICARDIAL, UNIPOLAR LEAD 4951
  6.  K842145  TRANSVENOUS TINED VENTRICULAR LEAD
  7.  K844687  MEDTRONIC MODEL 6912
  8.  K844974  MEDTRONIC 5061 ENDOCARDIAL PACING LEAD
  9.  K850968  MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
  10.  K851890  MEDTRONIC 5064
  11.  K852356  MEDTRONIC MODEL 5561
  12.  K894976  ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
  13.  K900627  MODEL 5866-34 LEAD ADAPTOR KIT
  14.  K904575  MODEL 5866-37M LEAD ADAPTOR KIT
  15.  K910630  MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
  16.  K911048  MODEL 5857-3M LEAD END CAP KIT
  17.  K911302  MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
  18.  K911827  MODEL 5866-9M & MODEL 6981M
  19.  K915724  MODEL 6984M LEAD EXTENDER KIT
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 8
Oversensing 5
Fracture 5
Low impedance 5
Fitting problem 4
Failure to capture 4
No Information 4
High capture threshold 4
Unknown (for use when the device problem is not known) 3
Defective item 3
Connection issue 3
Device sensing issue 2
Impedance issue 2
Material integrity issue 2
Failure to disconnect 2
Device remains activated 2
Artifact 2
Break 2
Electrical issue 2
Mechanical issue 2
Capturing issue 2
Output issue 1
Misapplication 1
Normal 1
Insulation, hole(s) in 1
Failure to pace or properly pace 1
Performance 1
Pocket stimulation 1
User used incorrect product for intended use 1
Device expiration issue 1
Adaptor, failure of 1
Component(s), broken 1
Elective replacement 1
Failure to sense 1
Sensitivity 1
Inappropriate shock 1
Use of Device Issue 1
Structural problem 1
High sensing threshold 1
Device displays error message 1
Ambient noise issue 1
Dislodged or dislocated 1
Total Device Problems 117

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