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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, pacing and cardioversion, temporary, epicardial
Regulation Description Cardiovascular permanent or temporary pacemaker electrode.
Definition The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.
Product CodeNHW
Regulation Number 870.3680
Device Class 2


Premarket Reviews
ManufacturerDecision
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High impedance 31
No code available 29
Fracture 14
Failure to capture 9
Low impedance 4
Device sensing issue 4
Material integrity issue 3
No Information 3
Impedance issue 2
Device operates differently than expected 2
Connection issue 1
Oversensing 1
Pocket stimulation 1
Difficult to remove 1
Failure to convert rhythm 1
Undersensing 1
Use of Device Issue 1
Device damaged prior to use 1
Total Device Problems 109

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