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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
No Known Device Problem 31
Device operates differently than expected 17
High impedance 12
Device displays error message 7
Break 5
Low battery 4
Failure to deliver energy 3
Battery issue 3
Charging issue 2
Low impedance 2
Therapy delivered to incorrect body area 2
Inappropriate shock 2
Malposition of device 2
Intermittent continuity 2
Incorrect display 1
Electro-magnetic interference (EMI) 1
Migration of device or device component 1
No device output 1
Difficult to Program or Calibrate 1
Delayed charge time 1
Improper or incorrect procedure or method 1
Connection issue 1
Noise, Audible 1
Electromagnetic compatibility issue 1
Material deformation 1
Material integrity issue 1
Total Device Problems 106

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