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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 19
High impedance 13
Device displays error message 7
Break 6
Inappropriate shock 5
Low battery 5
Charging issue 5
Low impedance 4
Battery issue 3
Malposition of device 2
Delayed charge time 2
Unstable 2
Improper or incorrect procedure or method 2
Intermittent continuity 2
Pocket stimulation 2
Failure to deliver energy 2
Therapy delivered to incorrect body area 2
Communication or transmission issue 2
Material deformation 1
Positioning Issue 1
Noise, Audible 1
Difficult to Program or Calibrate 1
Electro-magnetic interference (EMI) 1
Migration of device or device component 1
Total Device Problems 122

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