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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, brain, implanted, for behavior modification
Product CodeMFR
Device Class Humanitarian Device Exemption

Device Problems
Device operates differently than expected 10
No Known Device Problem 9
High impedance 9
Break 5
Therapy delivered to incorrect body area 2
Inappropriate shock 2
Low battery 2
Device displays error message 2
Malposition of device 2
Charging issue 2
Delayed charge time 1
Improper or incorrect procedure or method 1
Low impedance 1
Incorrect display 1
Electro-magnetic interference (EMI) 1
Failure to deliver energy 1
Migration of device or device component 1
No device output 1
Difficult to Program or Calibrate 1
Noise, Audible 1
Electromagnetic compatibility issue 1
Material deformation 1
Total Device Problems 57

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